The Food and Drug Administration is questioning the benefits and risks of a new rheumatoid arthritis drug created by Pfizer, Inc. Some possible risks of taking the drug, called tofacitinib, include an increase of lymphoma cancer cells, as well as infections. The purpose of the drug is to reduce swollen and tender joints. Pfizer could regain its renowned reputation since their release of Viagra over 10 years ago.
If the arthritis drug’s benefits are proven to trump its risks, and the drug approved, revenue is expected to reach $2 billion to $3 billion a year. The arthritis drug would be the first antirheumatic drug to be taken by mouth. Rheumatoid arthritis poses as one of the most lucrative diseases, earning drug companies $20 billion a year, as 1 percent of the American adult population suffers from the disease.
All patients are waiting for is the approval of FDA staff, to be determined in August. Pfizer plans for the arthritis drug to be made available if and as soon as they gain approval to do so.
"We continue to expect a positive panel outcome, after extensive discussions of the issues mentioned above," said Michael Tong, analyst at Wells Fargo.
While Pfizer presented x-rays of the drug’s effects to prove that it worked, the FDA was not convinced that the drug was preventing or slowing the damage rheumatoid arthritis causes.
Since there are other treatments to rheumatoid arthritis that avoid the mentioned side effects, the FDA awaits reassurance that the arthritis drug slows down structural damage caused by the disease
Other treatments include injectable arthritis drugs called Humira, Enbrel, a product of Amgen Inc. and Johnson & Johnson’s Remicade. All of these are on the higher priced end, and all block a protein called tumor necrosis factor, which is related to inflammation.
Humira has earned Abbot Laboratories, Inc. $8 billion in sales annually, and the approval of tofacitinib would pose as a cheaper competitor to the arthritis drug industry.