It's becoming painfully predictable at this point, but the latest setback for GlaxoSmithKline
By postponing its review of romiplostim, a rival idiopathic thrombocytopenic purpura (ITP) compound from Amgen
If the agency takes the full three extra months to make an approval decision on Promacta, its review date should be on or around Sept. 19. Don't assume that date's set in stone; other drugmakers like Cardiome
Ligand needs Promacta approved to juice up its revenue. Its only currently marketed drug is the pain compound Avinza, sold by partner King Pharmaceuticals
Last month, Promacta was subjected to a relatively positive FDA advisory panel hearing. Although the panel abstained from voting on whether to recommend delaying approval pending more data, it did vote 16-0 that the drug "demonstrated a favorable risk-benefit profile" for short-term ITP treatment.
Promacta's delay is just one of the FDA's many pushed-back review dates this year; aside from some biologics, nearly every new drug has faced postponements. Investors should probably assume at least an additional three-month review period for any New Drug Applications submitted to the agency, given this current harsh regulatory environment.