Les Laboratoires Servier SAS said its phase III trial called Indigo with vorasidenib as a monotherapy for patients with residual or recurrent isocitrate dehydrogenase (IDH)-mutant low-grade glioma met its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis were statistically significant and clinically meaningful in PFS as well as TTNI, said Servier, which gained the pan-IDH1/2 inhibitor from Agios Therapeutics Inc. in December 2020.

Leqembi that, CMS

The U.S. Veterans Health Administration (VA) is being applauded for doing what Medicare has refused to do – offer coverage of Alzheimer’s drug Leqembi (lecanemab) to veterans in the early stages of the disease. Under the decision announced yesterday, the Eisai Inc. drug, which was granted accelerated approval in January, will be listed as a nonformulary drug that must be prescribed by a VA-board certified neurologist, geriatric psychiatrist or geriatrician who specializes in treating dementia. The Centers for Medicare & Medicaid Services, on the other hand, has indicated it won’t cover the anti-plaque monoclonal antibody outside of select clinical trials until it has the evidence of clinical benefit it needs to decide whether the drug is “reasonable and necessary.”

Astellas’ fezolinetant meets primary endpoints in phase III study for vasomotor symptoms due to menopause

Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause. It is not approved for use anywhere in the world, and regulatory applications for fezolinetant are under review in the U.S., EU, Switzerland and Australia. If approved, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause.

Livzon licenses GERD drug from Onconic in $127.5M deal

Livzon Pharmaceutical Group Inc. licensed rights to zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, from Onconic Therapeutics Inc. in a $127.5 million deal. Under the agreement, Livzon obtains the exclusive rights to develop, license, manufacture and commercialize the candidate in greater China. In turn, Onconic will obtain a $15 million up-front payment, and up to $112.5 million in development, licensing and commercialization milestone payments.

China’s NMPA clears Shanghai Shengdi’s adebrelimab for extensive SCLC

China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.

Also in the news

Acadia, Acelrx, Adamis, Algotx, Alora, ALX Oncology, Alzecure, Aridis, Asahi Kasei, Betterlife, Biogen, Bio-Thera, Biovie, Bryn, Calliditas, Cambrian, Can-Fite, Cingulate, Clearmind, Crispr, DEM, Gensight, Horizon, Iliad, Indegene, Invex, ITM, Leo, Luye, Mersana, Miravo, Okyo, Olatec, Oryzon, Pliant, Switch, Teitur Trophics, Vectivbio, Vesigen