Basilea wins hard-fought FDA nod for antibiotic

2024-04-04

上市批准引进/卖出临床3期

Switzerland-based Basilea Pharmaceutica has finally won U.S. FDA approval for its broad-spectrum cephalosporin intravenous antibiotic — in three indications.

Ceftobiprole, branded Zevtera, is now approved in the U.S. for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients with community-acquired bacterial pneumonia (CABP).

The SAB indication, which includes those with right-sided infective endocarditis, is especially notable, given the current lack of treatments. These bloodstream infections are caused by methicillin-susceptible and methicillin-resistant isolates, MSSA and MRSA.

The approvals are a long-fought win for Zevtera, which will now have 10 years of market exclusivity in the U.S. after a regulatory journey that has lasted more than a decade.

Ceftobiprole was first approved in Canada in 2008 for the treatment of complicated skin and soft tissue infections. It has since notched approvals throughout Europe for patients with hospital-acquired bacterial pneumonia (HABP) and CABP. Basilea says it has license and distribution agreements for the drug covering more than 80 countries.

But the U.S. story has been different. In 2008, the FDA handed Basilea and then copartner, J&J, a CRL for ceftobiprole for the treatment of complicated skin and skin structure infections. The agency recommended additional site audits be conducted. A year later, the partners were handed a second CRL for the same indication, with the FDA then recommending the partners conduct additional clinical studies.

In 2014, Basilea attempted to get approval for ceftobiprole for the treatment of pneumonia, but were shot down after the FDA said U.S. approval would require additional phase 3 data.

Now, with an FDA approval finally in hand, Basilea is looking for a U.S. partner. "Whilst our initial goal was to have announced a commercial partnership by the time of approval of Zevtera in the US, in order to explore fully all potential partnering opportunities, we now expect to complete the process around mid-year," said Adesh Kaul, Basilea CFO.

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