Basilea gets FDA approval for antibiotic

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Swiss pharmaceutical manufacturer Basilea has received U.S. Food and Drug Administration (FDA) approval for its antibiotic Zevtera (ceftobiprole) for three different types of infections.

The FDA approvals include the use of Zevtera for adults with acute bacterial skin and skin structure infections (ABSSSI) and Staphylococcus aureus bacteremia (SAB), as well as for both adult and pediatric patients three months and older with community-acquired bacterial pneumonia (CABP).

The approval provides a new antibiotic option in the U.S., where most available antibiotics have been on the market for decades, increasing the risk of antibiotic resistance.

“We are very pleased that the FDA approved Zevtera for all three indications that were submitted with the [New Drug Application] NDA, including a pediatric labelling,” Dr. Marc Engelhardt, chief medical officer of Basilea, said in a statement. “This approval is a landmark for ceftobiprole and reflects its broad clinical utility. The indication in adult patients with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates, MSSA and MRSA, addresses a real medical need, as current treatment options are limited.”

The FDA granted Zevtera Priority Review, Fast Track, and Qualified Infectious Disease Product designations for all three indications.

“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” said Dr. Peter Kim, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, in a statement.

Basilea’s chief financial officer, Adesh Kaul, said in the statement that while the firm had initially planned to acquire a partner to commercialize Zevtera in the U.S. by the time of its FDA approval, it now aims to complete this process by mid-year “in order to explore fully all potential partnering opportunities.”

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