GSK plc GSK announced that the European Commission has authorized its respiratory syncytial virus (RSV) vaccine, Arexvy, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in older adults (60 years and older).
The approval was expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use had issued a positive opinion recommending approval of Arexvy for older adults in April. GSK expects to launch Arexvy in Europe ahead of the 2023 RSV season, which typically starts in autumn.
The approval of the RSV vaccine is based on data from the positive pivotal AReSVi-006 phase III study in which the vaccine led to a statistically significant and clinically meaningful overall efficacy of 82.6%.
Arexvy was approved by the FDA for older adults in May. This was the first RSV vaccine for older adults to be approved anywhere in the world. GSK’s RSV vaccine is under review in Japan and some other countries.
GSK’s stock has declined 1.5% this year so far compared with a decline of 7.3% for the industry.
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Pfizer’s PFE RSV vaccine, Abrysvo, was also approved by the FDA in late May for older adults, being the second RSV vaccine to be approved for this age group in the United States.
Older adults, young infants and people with some chronic medical conditions are at maximum risk to get lower respiratory tract infections (LRTI)-RSV disease. The approval of Abrysvo and Arexvy is expected to provide protection to older adults in the anticipated RSV season this fall. The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to have a meeting on Jun 21 to give its recommendation for the proper use of RSV vaccines in older adults.
AstraZeneca AZN and Sanofi’s SNY RSV vaccine called Beyfortus/nirsevimab was approved in Europe for protection against LRTI caused by RSV in newborns and infants in November 2022. A similar application is under review in the United States, with an FDA decision expected in the third quarter of this year. The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi.
Pfizer has also developed an RSV vaccine for infants through maternal immunization. The vaccine candidate is under FDA review for preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. A decision from the FDA is expected in August.
Moderna is also developing an mRNA vaccine, mRNA-1345, targeting RSV in a phase III study, ConquerRSV, in older adults. The study met the primary efficacy endpoints, per top-line data announced in January. Based on these results, Moderna expects to file for regulatory approval. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations.
In a separate press release, GSK announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking expanded approval for Jemperli (dostarlimab) for primary advanced or recurrent endometrial cancer.
The sBLA seeks approval of Jemperli in combination with chemotherapy for the treatment of mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. The regulatory application seeking approval for Jemperli was based on pivotal data from Part 1 of the RUBY phase III study. The FDA granted priority review to the sBLA with a decision expected on Sep 23.
In endometrial cancer, Jemperli is currently approved to treat adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen. If the potential new indication is approved, Jemperli can be prescribed earlier in treatment in combination with platinum-containing chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.
A similar application seeking expanded use of Jemperli in endometrial cancer is also under review in the EU.
GSK currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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