Basilea Pharmaceutica Ltd, based in Allschwil and traded on the SIX Swiss Exchange under the symbol BSLN, has announced that the US Food and Drug Administration (FDA) has given approval for ZEVTERA® (ceftobiprole medocaril sodium for injection). This drug is now cleared for treating Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including cases with right-sided infective endocarditis, as well as acute bacterial skin and skin structure infections (ABSSSI) in adult patients. Moreover, it has received approval for the treatment of community-acquired bacterial pneumonia (CABP) in both adult and pediatric patients aged 3 months to less than 18 years old.

David Veitch, CEO of Basilea, expressed his enthusiasm about the FDA's decision, seeing it as a significant advancement in bringing ZEVTERA to patients in the US. The approval also grants ZEVTERA ten years of market exclusivity from the date of approval, with the US market being considered a pivotal global commercial opportunity for the brand.

Dr. Marc Engelhardt, Basilea's Chief Medical Officer, emphasized the comprehensive approval of ZEVTERA for all three indications submitted with the New Drug Application (NDA), including pediatric labeling. He underlined the broad clinical utility of ZEVTERA, particularly its significance in addressing medical needs such as complicated Staphylococcus aureus infections.

The approval was supported by robust clinical data from phase 3 studies, including ERADICATE (SAB) and TARGET (ABSSSI), as well as a phase 3 study in CABP. Dr. Vance G. Fowler, Jr., a key investigator, stressed the urgent need for more treatment options for complicated Staphylococcus aureus infections, particularly those involving methicillin-resistant strains (MRSA).

Basilea also provided insights into the financial aspects and partnership opportunities associated with ZEVTERA's commercialization. Adesh Kaul, Basilea's CFO, discussed the company's efforts to secure commercial partnerships and expedite launch timelines post-approval.

Basilea's phase 3 program for ceftobiprole has received significant funding from the US Department of Health and Human Services, which underscores the importance of this antibiotic in addressing critical medical needs.

ZEVTERA, the brand name for ceftobiprole medocaril sodium for injection, is an advanced generation cephalosporin antibiotic known for its rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including MRSA. It is marketed under various brand names globally, with different indications tailored to specific regions.

 

Source: globenewswire.com

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