Friday, 4 October 2013

Ligand and Pfizer's Aprela (Duavee) approved despite government shutdown, Ligand stock up 10% intraday

The FDA kept its promise on delivering a verdict for Ligand (LGND) and Pfizer's (PFE) Aprela on Oct 3, 2013. The drug was approved despite low expectations. 

Aprela (now known as Duavee) is a novel combination drug of Bazedoxifene and Conjugated estrogens (Premarin) for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis in non-hysterectomized women.

The drug was approved amidst low hops and safety speculations. Pfizer has previously struggled with gaining approval of bazedoxifene on its own, having had the drug previously rejected by the FDA. The new combination, however, includes conjugated estrogens isolated from pregnant mares' urine, sold under the name Premarin since 1942 indicated for hormone replacement therapy. 

The drug may have a hard time appealing to physicians, particularly as non-hormonal competitors indicated for hot flushes have recently reached the market - OKed Hisamitsu Pharmaceutical's Brisdelle was approved by the FDA in June.

Ligand's stock gained nearly 10% on the news on Oct 3rd.