The U.S. Food and Drug Adminstration (FDA) has approved Basilea’s New Drug Application for their antibiotic treatment ZEVTERA for three clinical indications, paving their way into the U.S. market. Meanwhile, ONWARD Medical submitted their application for FDA clearance to market their ARC-EX therapy to improve or restore hand and arm function after spinal cord injury to patients in the U.S.
Basel-based startup Basilea Pharmaceutica announced the FDA approval of ZEVTERA, their antibacterial treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients with community-acquired bacterial pneumonia (CABP). The treatment shows rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. So far, the biopharmaceutical company has entered into license and distribution agreements covering more than 80 countries.
The New Drug Application (NDA) for ZEVTERA by the FDA was supported by clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB)1 and TARGET (ABSSSI),2 and a phase 3 study in CABP. This phase 3 program was funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA). Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.
David Veitch, CEO of Basilea, stated, “(…) ZEVTERA has 10 years of market exclusivity from the date of approval, and we believe the US provides the most important global commercial opportunity for the brand.
Medtech startup ONWARD to set foot in the U.S. market
ONWARD Medical, the medtech company building spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), submitted its De Novo application to the FDA for their ARC-EX System. The ARC-EX System delivers ARC-EX Therapy™ - targeted, programmed electrical stimulation – transcutaneously to the spinal cord to increase strength, movement, and function of the upper limbs after SCI. Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical.
“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”
The De Novo application follows the Company’s global pivotal study - called Up-LIFT - the first large-scale pivotal study of transcutaneous spinal cord stimulation. The study investigated the safety and effectiveness of ARC-EX Therapy in improving upper limb strength and function in 65 study participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the United States, Canada, the United Kingdom, and the Netherlands. The study met all primary safety and effectiveness endpoints and demonstrated that 72% of participants responded to ARC-EX Therapy, showing improvement both in strength and function.
In parallel to the foundational work in the U.S., ONWARD Medical is preparing for regulatory submission in Europe.
(Press releases / SR)
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