After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally-delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered.
Exelixis Inc.’s positive phase III top-line data June 22 with zanzalintinib (zanza) in colorectal cancer had Wall Street speculating anew about the odds with the tyrosine kinase inhibitor in an important indication.
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
Puretech Health plc’s rollout May 20 of more phase IIb data with deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis (IPF) perked optimism for that compound – a deuterated form of p38 MAP kinase inhibitor pirfenidone – as well as others in the busy therapeutic space.
Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
The joining of psychedelic specialists Beckley Psytech Ltd. and Atai Life Sciences can now go ahead after the pair announced positive top-line results from the phase IIb study of BPL-003, an intranasal formulation of 5-MeO-DMT benzoate.
Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
Edgewise Therapeutics Inc. CEO Kevin Koch speculated that “perhaps a different environment at the FDA” from four months ago led to reviewers’ caution on sevasemten, his firm’s fast skeletal myelin inhibitor for Becker muscular dystrophy and Duchenne muscular dystrophies.
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