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The Medicines and Healthcare products Regulatory Agency (MHRA) has on Friday approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in adults and adolescents aged 12-years-old and older who weigh 45kg or more. The medicine was approved via a fast-track approval process for medicines, known as the International Recognition Procedure (IRP), which allows the MHRA to consider the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The decision follows an approval for the drug by the US Food and Drug Administration (FDA). This is the first time the MHRA has approved a new medicine following FDA approval. The MHRA said it considered the assessment made by the US regulator as part of its own review, facilitating a rapid approval process. APDS is an inherited disorder where the patient is unable to fight infections because the immune system does not work properly. The main symptoms usually occur in the first two years of life and include repeated lung infections and a failure to grow and develop normally.

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

People are advised to be mindful of medications that may cause sun reactions, and to watch out for dodgy hay fever treatments and fake weight loss pens. For those traveling abroad, the MHRA advises considering the suitability of medicines available to reduce the risk of contracting tropical diseases. Dr Alison Cave, Chief Safety Officer at the MHRA, said: "The summer is an exciting time for many of us, as we take time off to travel and enjoy the warmer weather. "But it is important to understand what this time of year means for our medicines and medical devices, and take the precautions necessary to use products safely and protect ourselves." Watch out for dodgy hay fever treatments Millions of Britons suffer from hay fever symptoms in the summer. The MHRA advises consulting a healthcare professional to find the best treatment for your symptoms. People are also warned to be cautious of medicines advertised as hay fever treatments but not approved for use in the UK, such as Kenalog. This is a prescription-only steroid injection licensed as a medicine for other conditions, but not for the treatment of hay fever.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

UK regulator has approved a second oral antiviral for early treatment of Covid-19 in high-risk adults, after molnupiravir. The Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod for a new treatment called Paxlovid (PF-07321332 and ritonavir), after finding it safe and effective at reducing the risk of hospitalisation and death in people diagnosed with mild Covid-19 infection. Developed by Pfizer, Paxlovid prevents the multiplying of virus, helping the body to overcome the infection. A clinical trial for the treatment in high risk individuals revealed that a five-days course of Paxlovid reduces the risk of hospitalisation and death by 89 per cent. It further revealed that Paxlovid is most effective when taken in the early stage of infection. Dr June Raine, MHRA chief executive, said: "We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage."

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

A new cancer treatment for adults with stomach (gastric) and gastro oesophageal junction cancer has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) this week. According to the MHRA, Zolbetuximab, a monoclonal antibody, is designed to target and destroy specific cancer cells, offering a new option for patients whose cancer is inoperable or has spread. The new targeted cancer treatment for gastric and gastro-oesophageal junction cancer is administered intravenously in combination with standard chemotherapy regimens and is typically given every two to three weeks under the supervision of an experienced oncologist. Zolbetuximab is indicated for patients whose tumors are positive for the Claudin18.2 (CLDN18.2) protein and negative for the Human epidermal growth factor receptor 2 (HER2) protein.

Britain has become the first country to approve a Codiv-19 vaccine that targets both the original and Omicron variant of the virus. Medicines regulator MHRA approved the so-called bivalent vaccine made by US drug company Moderna as a booster for adults. The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said. The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5. "The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA chief executive June Raine said in a statement. "What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved lecanemab (Leqembi) for use in the early stages of Alzheimer's disease, following a thorough review of the drug's benefits and risks. Developed by Japanese pharmaceutical company Eisai, lecanemab is the first treatment for Alzheimer's disease licensed for use in Great Britain, with evidence indicating its potential to slow the disease's progression. Although the MHRA has granted a product license for the medicine, there are concerns about its cost and the potential delay before it becomes accessible to NHS patients. Pharmacist Thorrun Govind told Talk TV that the National Institute for Health and Care Excellence (NICE) is expected to make a final decision on its cost and availability by the end of the year. She highlighted that the drug is currently approved for private use, and that NICE will next evaluate it, weighing patient care against the value for taxpayers, with a final decision expected later this year.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

The Medicines and Healthcare products Regulatory Agency (MHRA) has awarded marketing authorisation to CStone Pharmaceuticals for sugemalimab (Eqjubi) as a first-line treatment for non-small cell lung cancer (NSCLC) in the UK. NSCLC is the most common form of lung cancer, accounting for around 80 to 85 out of 100 cases. Sugemalimab is now approved as a first-line treatment, in combination with platinum-based chemotherapy, for adult patients with metastatic NSCLC who do not have EGFR-sensitive mutations or ALK, ROS1, or RET genomic alterations. This UK approval follows its recent authorisation by the European Commission, marking the second international approval for sugemalimab. CStone's CEO Dr. Jason Yang described the UK's approval as a significant milestone in their global expansion strategy. "Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world's second-largest pharmaceutical market, the EU. "Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year's ESMO Congress, further confirmed sugemalimab's value in the frontline treatment landscape for metastatic NSCLC," he said.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday (9 January) announced that the novel type 2 oral polio vaccine (nOPV2) has been quality-assured (prequalified) by the World Health Organization (WHO). Developed by a team including scientists from the MHRA, nOPV2 is considered a safer polio vaccine that helps to protect children from the disabling and life-threatening disease and lower the risk of vaccine-derived outbreaks. The vaccine received WHO Emergency Use Listing three years ago, and since then 950 million doses have been delivered worldwide. The UN health agency's decision to add it to the list of prequalified vaccines is based on the analysis of outcomes in vaccinated populations that has confirmed strong safety profile and effectiveness.

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk of serious heart problems and strokes in adults who are obese or overweight. Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support. The latest approval establishes it as the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2. Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving over 17,600 participants. The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.

Britain has approved Novavax's Covid-19 vaccine for use in those 18 years of age and older, the country's medicines regulator said on Thursday (February 3), bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day. "We are continuing our vital safety work in monitoring the use of all Covid-19 vaccines, to ensure that their benefits in protecting people against Covid-19 disease continue to outweigh any risks," MHRA chief executive June Raine said.

UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old. The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday (December 22). Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data. These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said. Raine said: "We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.

Britain's Covid booster campaign is set to kick off this September, after the country became the first in the world to approve an Omicron-adapted shot. Around 26 million people in Britain are estimated to be eligible for an autumn Covid-19 booster, having had at least two Covid vaccine doses already, a UK Health Security Agency (UKHSA) spokesperson said. The preference is to deploy what is known as a "bivalent vaccine" that targets both the original virus and the Omicron variant through the autumn campaign, but that will depend on the health regulator (MHRA) approving such shots and the state of vaccine supplies. The UK's Joint Committee on Vaccination and Immunisation (JCVI) has advised boosters should be given to over-50s, individuals in clinical risk groups, frontline workers and care-home staff ahead of the winter, when respiratory viruses are typically at their peak. On Monday (August 15), the MHRA gave Moderna's bivalent shot conditional approval. The endorsement of the vaccine is based on data that showed it produced a marginally better immune response against some Omicron variants, versus the original novel coronavirus - although whether that translates into stronger protection against serious disease is unclear.

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.