Celgene Corp based in northern California, has won U.S. Food and Drug Administration approval for a treatment that fights a deadly blood cancer. The disease will be diagnosed this year in more than 22,000 people in the U.S.
Celgene’s drug Pomalyst also referred to as Pomalidomide received its approval for use with patients that have multiple myeloma and have failed with two prior drugs including Takeda Pharmaceuticals’ Velcade and Reylimid from Celgene.
Sales of Pomalyst could reach $1.1 billion by the beginning of 2017. Kyprolis is manufactured by Onyx Pharmaceuticals and is a similar drug that was approved back in July of 2012. Pomalyst’s application for approval with the FDA was submitted under an accelerated program for quicker approvals of medications that have promising results from clinical trials and treat serious diseases, so they might reach the market quicker.
The new medication must carry a box warning that warns users of possible blood clots and will warn pregnant women not to use the drug. The drug could lead to life threatening birth defects and women who take Pomalyst must first take a pregnancy exam prior to use and will have to adhere to a rigid contraceptive regimen.
Only patients with prescriptions will receive the medication through pharmacies that have been trained to dispense it. Reylimid is taken after the failure of one therapy and is Celgene’s top selling medication generating over $3.8 billion in annual sales.
Multiple myeloma is a cancer that attacks the white blood cells in the body that are created to protect the body form antibodies from the many different germs.
More than 15,000 patients this year will fail with their first two medications and 60% of them will be eligible to take the new medication.