Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future.
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism.
Veru Pharmaceuticals Inc.’s COVID-19 therapy VERU-111 (sabizabulin) failed to win full support from the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee, which was asked to decide about endorsing the firm’s request for an emergency use authorization to market the drug.
Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19.
The U.S. FDA’s device center recently advised companies that make tests for the COVID-19 pandemic that the emergency use authorization program for tests is winding down, albeit with a few exceptions.
China’s NMPA has granted emergency use authorization for two COVID-19 vaccines as boosters, Cansino Biologics Inc.’s inhaled vaccine Convidecia Air and Livzon Pharmaceutical Group Inc.’s recombinant protein vaccine. Convidecia Air is an aerosolized adenovirus type 5 vector-based vaccine. It is the first inhaled COVID-19 vaccine to be approved globally, according to Cansino.
Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.
It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course.
Now that Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19, it’s time for the CDC to weigh in. Once its Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine and make a policy recommendation, the vaccine will be available on the market.
