Disappointments for NicOx, as FDA panel rejects naproxcinod, and GlaxoSmithKline, which halts Promacta trial

US Food and Drug Administration news impacted negatively on French biotechnology firm NicOx, causing a setback for its osteoarthritis drug candidate, and for UK drugs giant GlaxoSmithKline, which has had to stop a trial of its Promacta (eltrombopag) in patients with thrombocytopenia due to chronic liver disease after a higher incidence of thrombosis was observed in patients taking the drug versus placebo.

This morning, NicOx revealed that the FDA's Joint Advisory Committees, including the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted by 16 to one with one abstention that they did not have sufficient evidence at this time to support the approval of naproxcinod, the first in a new class of drugs known as COX-inhibiting nitric oxide-donators (CINODs), for the relief of the signs and symptoms of osteoarthritis.
 Chairperson Kathleen O'Neil, Associate Professor of Pediatrics, University of Oklahoma College of Medicine, Division of Rheumatology, summarized the findings of the Advisory Committee meeting, saying there was enthusiasm for the potential of naproxcinod but more data was required from additional safety studies.

NicOx took a battering earlier this week, when its shares plunged nearly 24% to 5.44 euros, after the FDA released documents ahead of the advisory meeting, as a result of which agency staffers questioned the blood pressure benefits of the drug.