Pfizer's bid to expand the label of its Prevnar 13 pneumococcal vaccine garnered a near unanimous recommendation from FDA advisors. The Vaccines and Related Biologics Advisory Committee voted 14-1 to allow the drugmaker to market the vaccine for use in adults 50 and older, and supported accelerated approval. The adult indication would bring Prevnar 13, already approved for use in infants through adolescents, into further competition with Merck's Pneumovax 23. The PDUFA date is in early January 2012. The FDA is not bound to follow the recommendation.
The FDA approved Incyte's Jakafi (INCB 18424), the first drug sanctioned by the agency to treat patients with the bone marrow disease myelofibrosis. The PDUFA date was December 3. Novartis holds ex-US marketing rights to the oral JAK2 inhibitor, and Incyte plans to launch it in the US next week at a cost of $7,000 per month ($84,000/year). Myelofibrosis is not a big market, but a Jakafi approval in polycythemia vera (PV), a larger indication, could broaden sales. Collins Stewart analyst Salveen Richter says PV on its own represents a peak global opportunity of about $700 million. She forecasts total sales for the drug reaching $773.5 million by 2016.