Today, a brief rundown of news from The Food and Drug Administration and AstraZeneca, as well as updates from Acadia Pharmaceuticals and MeiraGTx that you may have missed.
The Food and Drug Administration has officially launched its new program designed to help boost U.S. drug manufacturing. Announced last year, the “PreCheck” initiative is supposed to make the regulation of new pharmaceutical factories more predictable, so those plants can be built and opened more quickly. The agency said it will select an initial cohort of facilities this year and base its decisions on “overall alignment with national priorities,” such as how quickly those facilities will begin making products for the U.S. market. — Ben Fidler
The FDA has rejected AstraZeneca’s request to approve a subcutaneous version of the lupus drug Saphnelo. AstraZeneca didn’t specify what precipitated the agency’s negative decision, but said Tuesday that it has since provided the FDA with its requested information and aims to work with the regulator to resolve the situation “as quickly as possible.” European regulators approved the new form of Saphnelo last month. AstraZeneca inherited rights to the drug via a partnership with Medarex — now owned by Bristol Myers Squibb — more than two decades ago. Bristol Myers gets royalties on U.S. sales. — Ben Fidler
The FDA has also granted a priority review to AstraZeneca’s cancer drug Datroway in an aggressive form of breast cancer. AstraZeneca reported last year that Datroway, an antibody-drug conjugate it sees as a future blockbuster, extended survival in a study of patients with triple-negative breast tumors who aren’t eligible for immunotherapy. AstraZeneca estimates about 70% of people with triple-negative tumors fit that description, leaving chemotherapy — which Datroway bested in testing — as first-line care. The FDA is expected to make a decision in the second quarter. — Ben Fidler
Acadia Pharmaceuticals said Monday that European drug regulators appear to be siding against its medication for a rare brain disorder called Rett syndrome. According to Acadia, an influential committee within the European Medicines Agency informed the company of a “negative trend vote” on its marketing application for “trofinetide,” which is already approved in the U.S., Canada and Israel under the brand name Daybue. The committee will take a formal vote later this month. Acadia already intends to request a re-examination of its application, a process that takes about four months and assigns different reviewers to assess a drug’s merits. — Jacob Bell
MeiraGTx will work with ZipBio, a Seattle-based startup focused on artificial intelligence drug discovery, to develop a gene therapy for the age-related eye disease geographic atrophy. MeiraGTx didn’t provide specific dollar figures involved, but said Tuesday that through the deal, it will receive rights to ZipBio therapies aimed at the complement pathway, a well-known target in geographic atrophy. MeiraGTX already has several eye-focused gene therapies in its pipeline, including a treatment it recently licensed to Eli Lilly. — Ben Fidler
