FDA approves new antibiotic for several hard-to-treat infections

04 Apr 2024
www.biopharmadive.com
Drug ApprovalLicense out/in
Dive Brief:
Swiss drugmaker Basilea Pharmaceutica on Wednesday won Food and Drug Administration approval for its drug Zevtera in a step that could help address the critical need for new antibiotics in the U.S.
The FDA cleared the drug for three different conditions: community-acquired bacterial pneumonia, Staphylococcus aureus bloodstream infections, and acute bacterial skin and skin structure infections. The approval covers adults with any of the three conditions as well as pediatric patients with pneumonia.
Basilea plans to announce a commercial partner for the U.S. market “around mid-year” and said interest increased as the approval drew near. In the meantime, the company is taking steps to ensure the time from signing a partner to launching the drug is as short as possible.
Dive Insight:
It’s been a long road for Basilea to reach the world’s biggest pharmaceutical market with Zevtera. The company first tried to win approval for Zevtera more than 15 years ago with its former partner, Johnson & Johnson. Setbacks in both the U.S. and European markets followed, with Basilea blaming J&J for faulty management of clinical trials for patients with a different set of skin infections.
J&J returned the rights to the drug to Basilea in 2010, and the company began winning regulatory clearances around the world and recruiting new partners. Basilea says it now has license and distribution agreements for the drug in more than 80 nations.
With the FDA approval, the company gains years of marketing exclusivity for what CEO David Veitch called in a statement “the most important global commercial opportunity.” In 2023, combined revenue for Zevtera and another drug, Cresemba, reached 150 million Swiss francs, or about $166 million.
With antibiotic resistance on the rise, new drugs are needed to treat a range of infections. But the economics of antibiotics are challenging. Usually, they only require a short course of treatment and when possible, doctors will opt for much cheaper generic medicines. As a result, companies bringing new antibiotics to market have often failed, one of the latest being Paratek Pharmaceuticals.
Basilea had some help with its bid to enter the U.S. market. U.S. government agencies including the Biomedical Advanced Research and Development Authority provided about $112 million in funding to develop Zevtera, Basilea said.
U.S. regulators based their approval on three multinational trials, including one published in The New England Journal of Medicine in September.
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