A day after getting US approval for the cancer drug Torisel (temsirolimus), Wyeth has fresh cause for celebration as a US state judge has overturned a $3 million jury verdict in litigation over the firm's hormone-replacement therapy Prempro.
A judge in Pennsylvania determined that the jury's verdict in favour of the plaintiff, Jennie Nelson, was improper, thus cancelling out a ruling in February. Then, the jury ruled that Wyeth failed to adequately warn the plaintiff about the risks associated with Prempro (conjugated estrogens/medroxyprogesterone acetate), and awarded compensatory damages of $2.4 million to Ms Nelson and $600,000 to her husband.
Wyeth faces at least 5,000 suits over Premarin and Prempro.
Constipation drug gets review date
Meantime Wyeth and partner Progenics Pharmaceuticals say that the US Food and Drug Administration has accepted the file for review of a New Drug Application for the firms’ subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care.
The FDA has set a Prescription Drug User Fee Act date of January 30 next year to complete its review of methylnaltrexone, a peripherally-acting opioid-receptor antagonist that is designed to treat OIC without interfering with pain relief. There currently is no approved medication that specifically targets the underlying cause of the condition to relieve constipation in this patient population.
The acceptance of the NDA submission results in a $5 million milestone payment to Progenics by Wyeth.