FDA grants priority review to ViiV drug for HIV
LONDON — The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.
The FDA gave the designation to dolutegravir, designed for use in combination with other antiretrovirual drugs in adults and adolescents. The agency gives priority review to drugs that offer significant improvement compared with products already on the market.
The FDA plans to have its review of ViiV's application finished by Aug. 17.
In other news, the FDA accepted a regulatory filing from GSK and Theravance for the experimental chronic obstructive pulmonary disease drug Anoro (umeclidinium bromide and vilanterol) and plans to have its review finished by Dec. 18.