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The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants. Applicants are now required to use the online 'Eligibility Checker' tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency's International Recognition procedure (IRP), which will become operational on 1 January 2024. The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to "facilitate a smooth and efficient process for marketing authorisation applicants."

The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) has seized a quantity of suspected unlicensed medical products including unlicensed versions of Botox, numbing agents and dermal fillers in Bolton, Greater Manchester. Officers from the MHRA and Greater Manchester Police conducted a raid across nine addresses in Bolton, Westhoughton and Leigh in the early hours of Thursday 13 July 2023, where two women and a man were arrested. Andy Morling, MHRA Deputy Director of Criminal Enforcement said: "Medicines like these are powerful and dangerous in the wrong hands, potentially leading to serious adverse health consequences. The criminals trading in these products are not only breaking the law, they also have no regard for your safety. It is illegal to advertise, sell or supply medicines such as these without the appropriate authorisation. If you see these products, or any other powerful medicines, being sold on social media or elsewhere online, think. It's unlikely to be legitimate. You can help the MHRA take action by reporting concerns to us through our Yellow Card scheme.

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) 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) on Tuesday authorised a Covid-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. The regulator authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised an innovative and first-of-its-kind gene-editing treatment for sickle-cell disease and transfusion-dependent β-thalassemia. Known as Casgevy (exagamglogene autotemcel), the treatment is based on the innovative gene-editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. Casgevy is the first medicine to be licensed that uses CRISPR, and it is to be used for treating patients aged 12 and over. To date, a bone marrow transplant has been the only permanent treatment option for these life-long conditions, which in some cases can be fatal. The MHRA's authorisation came after a rigorous assessment of its safety, quality and effectiveness.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new drug today (1 November) to treat severe alopecia areata. Litfulo is the new hard capsule medicine with a recommended dosage of just 50 mg per day. It contains an active ingredient, ritlecitinib, an enzyme inhibitor treatment for patients over 12 years. Ritlecitinib works by reducing the activity of enzymes in the body called JAK3 and TEC kinases that cause hair follicle inflammation. This reduction in inflammation leads to hair regrowth in patients with alopecia areata. Alopecia areata is an autoimmune disease, where the body's own immune system attacks hair follicles leading to hair loss on the scalp and other parts of the body.

Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a causal link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal behaviour, suicidal ideation, self-injury, or depression. GLP-1 receptor agonists , which contain active ingredients such as exenatide, lixisenatide, liraglutide, dulaglutide, and semaglutide, are commonly used to treat type 2 diabetes and obesity. In July 2023, concerns were raised about the safety of these receptor agonists after post-marketing reports suggested a potential risk of suicidal thoughts and self-harm associated with these medications. As a result, safety reviews were initiated by the Market Authorisation Holders (MAHs), evaluating the UK post-marketing data to assess the potential risks of these drugs. These reviews also examined the risk of depression in the interest of patient safety following reports of these side effects.

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) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024. Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe. According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week. "We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

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.

Maxwellia has revealed its plans to switch some of its medicines in the self-care category from prescription-only-medicine (POM) to a pharmacy (P) medicine. After authorising the switch of Maxwellia's two brands of desogestrel contraceptive pills, Lovima and Hana, MHRA has opened a public consultation on reclassification of Aquiette (overactive bladder treatment) 2.5mg tablets manufactured by the company to be made available from pharmacies. "Maxwellia is currently looking at a number of medicines which treat a range of conditions in major public health categories that can be 'switched' from needing a prescription to being conveniently bought at a local high street or supermarket pharmacy. With its foot firmly on the accelerator it has other applications under assessment with the MHRA, including women's health products," the company stated in a recent statement. "Push to convert more prescription medicines to pharmacy medicines will firmly position pharmacists at heart of nation's public health, helping futureproof NHS," the medicine said.

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.

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.

In what's seen as a major step forward for the treatment of schizophrenia, the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised a new Johnson & Johnson drug in Britain. Byannli is a six-monthly paliperidone palmitate (PP6M) and is the first long-acting injectable schizophrenia treatment which offers patients the potential for up to six months of symptom control and a reduction in their risk of relapse with only two doses a year. It is a long-acting injectable that works by dissolving and entering the bloodstream slowly, due to its extremely low water solubility, resulting in continuous absorption of paliperidone palmitate over a six-month period. "Schizophrenia is a chronic and severe brain disorder, and antipsychotic medication plays an important role in its treatment. However, many people with the illness experience relapses which are often caused by poor adherence to oral medication," said Prof David Taylor, director of Pharmacy and Pathology at the Maudsley Hospital.

A diabetes medicine, Mounjaro, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat overweight patients. The weight loss medication originally developed for Type 2 diabetes is now accessible to individuals aged 18 and over who are dealing with obesity and weight-related health issues. The active ingredient, tirzepatide, works by making the patient feel fuller and reducing food cravings. The injection helps individuals lose 20 per cent of their body weight, and are advised to follow a reduced-calorie diet and increase physical activity simultaneously. Although it is not authorised to use on the NHS as yet but future approvals can be predicted.

HRA Pharma is celebrating the 1st anniversary of Hana, the first type of daily oral contraception available in the UK without a prescription. The launch of Hana in 2021 followed the historic decision of the Medicines and Healthcare products Regulatory Agency (MHRA) to grant a marketing authorisation and marked a significant step forward in the women's contraception category. The company reports that pharmacists have embraced the reclassification and have found merit in using emergency contraception consultations as an opportunity to educate women on their over-the-counter contraception options. Alison Slingsby, innovations project manager at HRA Pharma, commented: "We have been delighted with Hana's reception - within weeks of launch, it quickly became the best-selling mini-pill without prescription, with more than 95 per cent market share, and has maintained this market leading position ever since. We previously had the experience of switching emergency contraceptive ellaOne to a P medicine, Hana is on track to match and eventually exceed the ellaOne volumes.

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription. The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the unborn baby if valproate-containing medicines are used in pregnancy. The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained in the manufacturer's original full pack. Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.

HRA Pharma's progestogen-only contraceptive pill, Hana, has won the 'Special Achievement Award' at the Nicolas Hall awards. The awards took place on May 5, 2022 in Athens. HRA's Marketing Director for the UK, Ireland and the Nordics, Kate Evans, was in attendance to represent the Hana team and accept the award. The Hana pill became available in July 2021 for women in the UK to purchase without a prescription following a pharmacy consultation. The launch has made it easier for women to access effective daily contraception. This reclassification made HRA Pharma one of the leaders in this new healthcare category. The switch followed the authorisation of reclassification of desogestrel by UK regulator MHRA. Hana was one of the first products to enter this new market.