The U.S. FDA named the first nine recipients of the recently unveiled commissioner’s national priority voucher (CNPV) program aimed at addressing unmet public health needs by shortening regulatory review times to as little as one to two months. For one of those firms, Disc Medicine Inc., which submitted an NDA for bitopertin for rare genetic disorder erythropoietic protoporphyria in September, that could mean a potential approval before the end of 2025.
Although type 2 diabetes tends to get more airtime, type 1 diabetes also had drawn a number of the developers to the table. Recently winning the attention of Wall Street is SAB Biotherapeutics Inc., which offered data during the European Association for the Study of Diabetes annual meeting. Vertex Pharmaceuticals Inc. and Biomea Fusion Inc. are among the other players.
With a new drug available to slow the progression of type 1 diabetes, Sanofi SA is partnering with two med-tech companies to increase screening for early-stage type 1 diabetes and identify eligible patients.
Classically, the diagnosis of type 1 diabetes comes after a patient presents with unexplained weight loss, extreme thirst and frequent urination and a lab test reveals off-the-charts blood glucose levels. At the 85th Scientific Sessions of the American Diabetes Association in Chicago, researchers highlighted two options – a blood test and a machine learning model – for diagnosing the disease much earlier in its progression, when damage to the pancreas' beta cells could be slowed.
Shares of Provention Bio Inc. (NASDAQ:PRVB) closed March 13 at $24.10, up $17.40, or 259%, after Wall Street learned that collaborator Sanofi SA intends to acquire the firm for $25 per share in cash, which works out to an equity value of about $2.9 billion. The transaction brings Paris-based Sanofi the type 1 diabetes (T1D) therapy Tzield (teplizumab-mzwv), approved by the U.S. FDA in 2022 as the first and only therapy to delay the onset of stage 3 disease in adults and in pediatric patients ages 8 and older with T1D that has reached stage 2.
Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 May 27 that the benefits of Provention Bio Inc.’s teplizumab outweighed its risks, but the vote was not a ringing endorsement of the anti-CD3 monoclonal antibody biologic that could be the first disease-modifying treatment for people at risk of developing type 1 diabetes (T1D).
Provention Bio Inc.’s diabetes candidate, teplizumab, is heading into a May 27 advisory committee meeting with a skinnier label than originally planned, which could signal a smoother path to approval. The positive briefing document the FDA put out Tuesday also suggested an approval path for what could be the first disease-modifying treatment available for type 1 diabetes (T1D).
