Chikungunya Vaccine(Technovalia)

The European Commission (EC) has granted marketing authorisation to Valneva’s single-dose chikungunya vaccine Ixchiq for use in individuals aged 18 years and older. Chikungunya is a mosquito-borne viral disease that causes symptoms including fever, severe joint and muscle pain, headache, nausea, fatigue and rash. The virus has now been identified in over 110 countries in Europe, Asia, Africa and the Americas, with more than 3.7 million cases reported in the Americas alone between 2013 and 2023. The EC’s decision on Ixchiq follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by positive results from a late-stage trial, which demonstrated a 98.9% seroresponse rate at 28 days after a single dose of the vaccine. This immune response was sustained for 24 months by 97% of study participants and was equally durable in younger and older adults, Valneva said. The company also recently shared further positive data for the vaccine in adolescents. The results showed that a single-dose generated a high and sustained immune response in an immunogenicity subset of adolescents who were chikungunya-negative at baseline, with a seroresponse rate of 99.1% after 180 days following vaccination compared to 98.8% after 29 days. The day 180 data also confirmed that a single dose of the vaccine was generally safe and well tolerated in adolescents, regardless of previous infection status. Juan Carlos Jaramillo, Valneva’s chief medical officer, said the approval “marks a crucial milestone toward making this vaccine available to as many European citizens as possible”. “It is critical to provide a vaccine solution not only to European travellers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks,” he said. The approval comes less than eight months after Ixchiq became the first chikungunya vaccine to be licensed anywhere in the world after receiving accelerated approval from the US Food and Drug Administration for use in individuals ages 18 years and older who are at an increased risk of exposure to the disease.

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. (Pixabay) Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. UPDATED: Monday, July 1 at 8:51 a.m. Sandoz and Samsung Bioepis' Pyzchiva, a biosimilar to Johnson & Johnson's Stelara, has gained FDA approval.  The agency provisionally endorsed the biosimilar as an interchangeable product, meaning that in some cases it can be substituted at the pharmacy counter without a doctor's permission. Sandoz will commercialize the biosimilar in the U.S. under the partnership between the companies. The biosimilar is set to reach the market in February of next year thanks to a settlement the partners struck with Johnson & Johnson in November. Pyzchiva is approved to treat plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults. In pediatric patients, the biosimilar is approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis.   Also on the biosimilar front, Formycon's biosimilar to Regeneron's blockbuster Eylea has gained an FDA nod. Branded as Ahzantive, the new biosim joins Formycon's Lucentis biosimilar on its roster of approved therapies.  The FDA approved Ahzantive to treat wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy and macular edema following retinal vein occlusion. Formycon did not detail its launch plans in its approval press release.   The European Commission has approved Valneva's Ixchiq as a single-dose vaccine to protect against chikungunya virus. Ixchiq is the world's first chikungunya vaccine, having gained prior approvals in the U.S. and Canada. Other regulatory reviews are progressing in the U.K. and Brazil, Valneva said in a press release. "In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected," Valneva's chief medical officer, Juan Carlos Jaramillo, M.D., said in a statement. "It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks."