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As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Pfizer, Rznomics, Sanofi, Satsuma, Sobi.
Five months after the first anti-CD20xCD3 T-cell engaging bispecific antibody, Roche Holding AG’s Lunsumio (mosunetuzumab), cleared U.S. FDA approval for follicular lymphoma, partners Genmab A/S and Abbvie Inc. won the agency’s approval for epcoritamab as the first subcutaneous CD20xCD3 bispecific antibody for treating diffuse large B-cell lymphoma.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Hologic, Neurophet, Thermo Fisher, Volta Medical.
The U.S. FDA granted clearance to two tests developed by Thermo Fisher Scientific Inc. to predict preeclampsia, Brahms PIGF plus Kryptor and Brahms sFlt-1 Kryptor. Both had previously received breakthrough designation. Preeclampsia, a hypertensive disorder, is the leading cause of maternal and fetal mortality and morbidity across the globe.
Efficacy data for Pfizer Inc.’s respiratory syncytial virus (RSV) vaccine proved convincing for members of the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee, which voted 14-0 May 18 in favor of Abrysvo’s effectiveness when administered during the second or third trimester of pregnancy to protect infants from birth to 6 months, with the adcom endorsing safety data in a 10-4 vote.
Trouble presaged by U.S. FDA concerns over potential drug-induced liver injury (DILI) caused by obeticholic acid (OCA) 25 mg came to pass during the Gastrointestinal Drugs Advisory Committee meeting May 19 on Intercept Pharmaceuticals Inc.’s accelerated approval effort with the compound.
Right on schedule the U.S. FDA gave its blessing for Krystal Biotech Inc.’s topical gene therapy, Vyjuvek (beremagene geperpavec, or B-VEC), an orphan drug, to become the first approved treatment for the rare skin condition dystrophic epidermolysis bullosa (DEB).
Less than a year after submitting their NDA and several weeks before the June 28 PFUFA date, Bausch + Lomb Corp. and partner Novaliq GmbH have been awarded U.S. FDA approval for Miebo, their perfluorohexyloctane eye drop formulation designed to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Antengene, Galera, Immupharma, Pepgen, Vifor, Westvac.
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