Basilea pushes back FDA submission for antibiotic over CMO issues
Basilea Pharmaceutica said it’s encountering a manufacturing delay that will affect when the company is able to submit its antibiotic ceftobiprole for FDA approval.
The Swiss biotech announced Tuesday that it will take an estimated three to six months to ensure that one of its third-party contract manufacturers will be ready for inspection by the FDA.
Basilea now expects to submit ceftobiprole, also known as Zevtera, to the FDA in the third quarter of this year, and a regulatory decision is expected in the second quarter of 2024, CEO David Veitch said in a news release. The biotech plans to submit the drug for three indications in the US, including Staphylococcus aureus bacteremia, community-acquired bacterial pneumonia, and acute bacterial skin and skin structure infections. In 2020, the drug was approved for treating community and hospital-acquired pneumonia in China and got marketing authorization in Brazil for the indications last year.
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