Markets

Basilea Pharma Submits NDA For Antibiotic Ceftobiprole

August 04, 2023 — 01:56 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - Basilea Pharmaceutica Ltd has submitted a New Drug Application to the FDA, seeking approval of its antibiotic ceftobiprole for treating patients in three indications: Staphylococcus aureus bacteremia, including right-sided infective endocarditis, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. The NDA submission includes clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB), TARGET (ABSSSI), and a phase 3 study in CABP.

Ceftobiprole has been designated a Qualified Infectious Disease Product, which provides for a Priority Review within eight months from submission. Provided that the NDA submission is accepted, the company expects a decision by the FDA on the NDA in the second quarter of 2024.

Basilea is a commercial-stage biopharmaceutical company headquartered in Switzerland. The company plans to commercialize ceftobiprole in the US through a partner and plans to enter into such a partnership prior to the FDA's decision on the NDA.

For More Such Health News, visit rttnews.com.

RTTNews
Founded in the late 1990s by Andrew Mariathasan in New York, with the goal of covering Wall Street for a new generation of investors, RTTNews has expanded steadily over the years to become a trusted provider of content for a wide array of subjects across several platforms. RTT's Financial Newswire is relied upon by some of the world's largest financial institutions, including banks, brokerages, trading platforms and financial exchanges.
More articles by this source

Tags

Markets

Latest Articles
Data is currently not available