FDA schedules adcomms for Entasis' antimicrobial treatment, Intercept's NASH hopeful
The FDA this morning announced two upcoming advisory committee meetings in April and May — with the goal of reviewing two drugs with a lot of history that have gone through multiple setbacks.
According to notices published in the Federal Register, the FDA is convening its Antimicrobial Drugs Advisory Committee on April 17 to discuss Entasis Therapeutics’ NDA for sulbactam-durlobactam for the treatment of Acinetobacter infections.
The biotech, spun out of AstraZeneca’s former antibiotics division in 2015, is gunning for the antibiotic to win approval to treat infections of Acinetobacter baumannii-calcoaceticus complex, including multidrug-resistant and carbapenem-resistant strains. Entasis’ NDA was accepted back in November and granted priority review, with a PDUFA date of May 29.
The drug is part of a deal with Zai Lab, a Shanghai-based biotech with an exclusive development and commercialization license in more than a dozen countries in the Asia-Pacific region, including China, Korea, Japan, the Philippines and New Zealand.
The biotech was once public on Nasdaq before being picked up last year by backer Innoviva, which bought out all the biotech’s shares at $2.20 apiece — taking the company private back in May.
Innoviva already owned 60% of the company at the time of the deal.
The other adcomm, scheduled for May 19, is gathering the FDA’s Gastrointestinal Drugs Advisory Committee to review Intercept Pharmaceuticals’ obeticholic acid to treat nonalcoholic steatohepatitis (NASH).
Intercept has had a rough history pushing this liver drug to market. Intercept’s NDA, which was given an action date of June 22, is the second attempt bringing this drug past regulators.
The FDA previously rejected obeticholic acid in 2020 after the agency became uncertain — per Intercept at the time — if the surrogate endpoint, reduction in liver fibrosis, from a Phase III trial would translate into clinical benefit.
The drug developer, after reporting a Phase III fail back in September 2022, highlighted interim analyses from a pivotal Phase III study, including one where patients on 25 mg of the drug saw “double the response rate of placebo in reduction in liver fibrosis stage without worsening of any of the three histologic components of NASH,” the biotech said back in January, calling the endpoint in line with FDA guidance.
Intercept CEO Jerry Durso said in a statement Friday, “We look forward to the opportunity to discuss with the Advisory Committee our clinical trial data.”