Latest news with #EuropeanMedicinesAgency
Medscape
6 hours ago
- Health
- Medscape
EMA Says No to Knee Cartilage Repair Therapy Jelrix
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended refusing marketing authorization for Jelrix (autologous cartilage-derived articular chondrocytes), a product intended to repair injury-related cartilage defects in the knee. Jelrix is an advanced therapy medicinal product that uses a patient's own cartilage cells that are expanded in a lab and then implanted back into the knee to repair the defect. It was developed for patients with symptomatic cartilage defects of 2 cm² to 12 cm² whose bones have finished growing. In its decision, the EMA cited concerns about the lack of data to ensure consistent quality of the medicine through its manufacturing process and control strategy. No Verifiable Improvement The application was supported by a main study involving 100 patients with cartilage defects in the knee. The primary effectiveness measure was the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS), which evaluates pain, symptoms, and quality of life on a 0-100 scale, with higher scores indicating fewer symptoms. Assessments were conducted at 24 and 60 months post-treatment. Results were compared indirectly to outcomes from a separate microfracture registry rather than via a randomized control group. While patients who received Jelrix showed improvement in their KOOS scores at 24 and 60 months, the EMA noted that the study lacked a comparator group. This means the improvements could not be definitively attributed to Jelrix, as they might have resulted from the surgery and rehabilitation all participants received. Therefore, the agency concluded that the benefits of Jelrix did not outweigh its risks. The company confirmed there are no ongoing clinical trials or compassionate use/expanded access programs involving Jelrix in the EU. The applicant, Tissue Engineering Technologies AG, may request reexamination within 15 calendar days of receiving EMA's opinion. If pursued, CHMP will reassess their application based on any additional data provided.
The Hindu
3 days ago
- Health
- The Hindu
Lenacapavir: After FDA approval, HIV pre-exposure prophylaxis injectable moving closer to EU approval
On July 25, The European Medicines Agency (EMA)'s advisory committee recommended Gilead Sciences' Lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Any recommendation by EMA's advisory committee has to be formally approved by the European Commission, which is expected later this year. The recommendation by the EMA's advisory committee comes about a month after the U.S. FDA on June 18, 2025 approved the injectable HIV-1 capsid inhibitor as a pre-exposure prophylaxis (PrEP). The World Health Organization welcomed the approval by FDA on June 19 and issued guidelines for use of Lenacapavir for HIV prevention on July 14. 'Offering additional pre-exposure prophylaxis (PrEP) choices has the potential to increase uptake and effective use of PrEP, and of HIV prevention overall, as it allows people to choose a method that they prefer,' the guidelines say. Studies have also shown that Lenacapavir can achieve significant viral suppression, even in cases where other drugs have failed. The FDA approved Lenacapavir is based on the 2024 results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated the safety and efficacy of the pre-exposure prophylaxis injectable across diverse populations and settings. The PURPOSE 1 was a Phase 3, double-blind, randomised trial to evaluate the safety and efficacy of twice-yearly, subcutaneous Lenacapavir for pre-exposure prophylaxis (PrEP) and was tested on 5,338 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The injectable was compared with an active control arm that received once-daily oral pre-exposure prophylaxis drug Truvada (emtricitabine-tenofovir disoproxil fumarate; F/TDF). There were zero HIV infections among 2,134 participants in the Lenacapavir group, while the active control group had 39 infections among 2,136 participants. In the PURPOSE 2 Phase-3 trial involving 3,265 participants in the modified intention-to-treat analysis, two participants were infected with HIV in the arm that received the injectable, while nine participants who received the active control PrEP oral drug Truvada (emtricitabine-tenofovir disoproxil fumarate; F/TDF) were infected. The background HIV incidence in the screened population (4,634 participants) was 2.37 per 100 person-years. The trial was carried out in of cisgender men, transgender, and nonbinary individuals across 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the U.S. Compared with the generic PrEP oral drug Truvada, which is extremely inexpensive and widely available, Lenacapavir costs $28,000 for two injections. Why would people ever prefer to use Lenacapavir considering the cost? 'Oral PrEP will be effective only if there is 100% adherence. The oral drug won't work even if it is missed for a day because the drug level will be only 24 hours,' says Dr. N. Kumarasamy, Chief and Director, VHS-Infectious Diseases Medical Centre, Voluntary Health Services, Chennai. 'People who have the highest risk such as sex workers and gay men have to take the drug every day. Taking a tablet every day, even for a deceased patient, is so difficult. They tend to miss a dose, which is why adherence is never 100%,' he says. 'Even in the case of on-demand PrEP, where people who want to indulge in unprotected sex have to take the oral drug two days before, then throughout the period of risky behaviour and continue for two more days after risky behaviour ends, adherence never goes beyond 85-90%. PrEP will work only if the adherence is 100%.' According to Dr. Kumarasamy, despite the oral tablet being inexpensive and easy to take, the adherence is less than ideal, the reason why people are moving towards long-acting injectables that prevent HIV infection for months after an injection. Cabotegravir, which was developed as pre-exposure prophylaxis (PrEP), underwent trials in many countries and was approved for use. Cabotegravir, which is administered intramuscularly every two months, was found superior compared with every day oral PrEP tablet, and started getting implemented in certain parts of the world, Dr. Kumarasamy says. 'Since Cabotegravir has to be administered every two months, people tend to forget. The new drug Lanacapivir has been found to be effective for six months in the trials. The injectable was developed in 2021 as treatment in people who no longer respond to other drugs as they have developed resistance,' he says. Because Lenacapavir was found to be long-acting, it was repurposed as a pre-exposure prophylaxis administered subcutaneously. 'Lenacapavir is a robust molecule and is the best solution in the absence of vaccines. Even if there is going to be an HIV vaccine one day, I'm sure people will have to take the vaccine every year or something. Like a flu shot, you know if at all they are going to develop a vaccine, people may have to take it every year or every six months as a booster dose. It may not be like a one dose that is effective for years,' Dr. Kumarasamy says. 'In the absence of a HIV vaccine, I think the pre-exposure prophylaxis every six months can be considered like a vaccine.' Gilead is developing the same molecule to be administered once a year instead of every six months. They are already working on that. But it will not be a subcutaneous form but as an intramuscular injection, he says. Licensing agreements On October 2, 2024, Gilead Sciences signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic Lenacapavir. Of the six generic manufacturers, four are in India. Besides signing agreement to license generic manufacturers to make the injectable, Gilead Sciences also said that it would 'support low-cost access to the drug in high-incidence, resource-limited countries at no profit until generic manufacturers are able to fully support demand'. These countries are: Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe. The company has licensed Dr. Reddy's Laboratories Limited, Emcure, Hetero and Mylan, a subsidiary of Viatris, to manufacture Lenacapavir in India. The companies will be permitted to supply to 120 countries. According to the press release, the agreements cover not only Lenacapavir for HIV prevention but also for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV. According to Dr. Kumarasamy one company has already started developing the drug and Lenacapavir may become available next year once the Indian drug regulator approves it based on the results of a safety study carried out in India. As per his estimate, the generic form of Lenacapavir will cost about $100 per dose.
Business Insider
3 days ago
- Business
- Business Insider
Europe Grants Limited Approval to Eli Lilly's (LLY) Alzheimer's Drug
The European Medicines Agency (EMA) has granted limited approval to Eli Lilly's (LLY) new Alzheimer's drug Kisunla, reversing an earlier decision to reject the drug over concerns of brain swelling and bleeding in patients. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. The treatment for early-onset Alzheimer's, which is administered via a monthly infusion, has already been approved in the U.S., United Kingdom (U.K.), Japan and China. In March, the European Medicines Agency human medicines committee rejected the drug, saying there was a risk of 'potentially fatal events' due to brain injuries and bleeding. But now, after re-examining the drug at the request of Eli Lilly, the medicines committee has recommended granting Kisunla marketing authorization for a limited number of patients who do not have a copy, or only have one copy, of the ApoE4 gene that puts them at a greater risk of Alzheimer's disease. Controlled Access The EMA said the treatment should be administered as part of a controlled access program and under the supervision of physicians trained in managing potentially dangerous symptoms. It also mandated measures aimed at mitigating risks, including more stringent rules for stopping treatment, and said that patients administered Kisunla must start with a low dose. 'This positive opinion marks a significant milestone in our efforts to bring (Kisunla) to eligible patients across Europe,' said Patrik Jonsson, President of Eli Lilly International, in a written statement. '(Kisunla) has the potential to make a meaningful difference for people living with early symptomatic Alzheimer's disease.' Is LLY Stock a Buy? The stock of Eli Lilly has a consensus Strong Buy rating among 19 Wall Street analysts. That rating is based on 16 Buy, two Hold, and one Sell recommendations issued in the last 12 months. The average LLY price target of $1,006.80 implies 26.02% upside from current levels.
Yahoo
3 days ago
- Business
- Yahoo
Pfizer (PFE) Receives CHMP Recommendation For Adapted COVID-19 Vaccine COMIRNATY
BioNTech SE and Pfizer recently received a positive recommendation from the European Medicines Agency for marketing authorization of their COVID-19 vaccine, which likely contributed to Pfizer's share price increase of 8% in the last quarter. The company's advancements in COVID-19 vaccine development, alongside other product-related announcements like the XTANDI and BRAFTOVI trial results, added weight to this upward movement. Despite legal challenges and declining earnings, Pfizer's focus on innovation and strategic partnerships like the one with XtalPi possibly countered broader market moves, which saw a smaller 1% increase in the same period. We've identified 3 warning signs for Pfizer that you should be aware of. Trump's oil boom is here — pipelines are primed to profit. Discover the 22 US stocks riding the wave. The recent positive recommendation from the European Medicines Agency for the COVID-19 vaccine developed by BioNTech SE and Pfizer has contributed to an 8% increase in Pfizer's share price over the last quarter. This news may provide a temporary boost to Pfizer's revenue and earnings forecasts, especially as the company continues to innovate amidst legal challenges and declining earnings. The authorization could enhance immediate market confidence in Pfizer's product pipeline, impacting future revenue projections positively. Over the past year, Pfizer experienced a total return of 13.78% including dividends, reflecting a challenging period for shareholders. When compared to the broader US market's return of 17.2% over the same period, Pfizer has underperformed, highlighting investor concerns over competitive pressures and revenue growth prospects. The current share price movement toward the analyst consensus price target of $29.23 suggests a cautiously optimistic outlook among some market participants. Analysts' revenue forecasts reflect potential declines due to increased competition for existing products, yet others anticipate that strategic shifts in research focus, especially in oncology, might mitigate future earnings risks. With a modest increase of 8% in shares largely tied to vaccine authorization, it underscores the uncertainty surrounding longer-term performance relative to bearish analyst expectations. Understand Pfizer's track record by examining our performance history report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include PFE. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Reuters
4 days ago
- Health
- Reuters
EU regulator backs Moderna's updated COVID vaccine
July 25 (Reuters) - The European Union's drug regulator has recommended approval of Moderna's (MRNA.O), opens new tab updated formulation of COVID-19 shot Spikevax, the vaccine maker said on Friday. The updated shot targets the LP.8.1 variant, part of the JN.1 lineage, to prevent COVID-19 in individuals six months of age and older, Moderna said. It expects to make the mRNA-based shot available for the 2025-26 vaccination season, pending a European Commission approval. Any recommendation by the European Medicines Agency's human medicines committee has to be formally approved by the EC, which usually follows the regulator's decision. Moderna had filed a marketing application for the review of its updated vaccine with the U.S. Food and Drug Administration in May.
