Pfizer’s Xeljanz Gets Approval From The FDA For A Second Indication

The U.S. Food and Drug Administration has announced that its Xeljanz drug has been approved to treat patients suffering from active psoriatic arthritis. In the U.S. Xeljanz is used in the treatment of patients suffering from rheumatoid arthritis and who are unable to tolerate methotrexate. Xeljanz also received approval in China and Europe nine months ago for the treatment of rheumatoid arthritis.

Xeljanz’s sNDA was filed seven months ago with the Food and Drug Administration and this came after encouraging data was obtained from trials conducted on the drug to evaluate its safety and efficacy. In the trials the primary endpoint was achieved and it was also found to be safe for use.

Active ulcerative colitis

Besides the new indication Pfizer is also looking to have Xeljanz approved for use as a treatment for active ulcerative colitis and the Food and Drug Administration is expected to give a response in March 2018. In the United States sales of Xeljanz in the three past quarters this year have increased by 44% year-over-year to reach a figure of $935 million. With the label expansion sales are expected to be boosted further.

The label expansion of Xeljanz comes in the wake of a report indicating that Pfizer’s move to launch a generic version of its erectile-dysfunction drug Viagra could end up saving millions of dollars for the healthcare system in the United States. Pfizer has already announced that the drug, which is currently sold at a price of $65 a pill, will be halved.

18 million men

According to Access Market Intelligence president, John Santilli, over 62 million men have used the drug and there will thus be enormous savings even on the part of the patients. In the United States approximately 18 million men have been diagnosed to be suffering from erectile dysfunction.

“Making a generic version of the pill will allow even more men who have not been able to afford it to try the generic version. With a less expensive alternative on the market, I see doctors prescribing and patients increasing,” said Santilli.

Per Santilli the savings could be in the range of $250 million. However, according to University of Michigan’s Erik Gordon, in the case of the healthcare system in the United States, the savings will be lower than is usually the case when a drug’s patent expires and it goes generic. This is because consumers paid for most of the prescriptions for Viagra and not the health insurance plans since some of plans consider the drug medically unnecessary.