The U.S. Food and Drug Administration extended by three months its review of Pfizer Inc’s experimental rheumatoid arthritis treatment tofacitinib, one of the most promising new drugs in the company’s pipeline, Reuters reports.
In July, Pfizer disclosed that the FDA sought a “routine” analysis of clinical trial data for the drug that could delay a decision by three months or more beyond the agency’s Aug. 21 deadline.
If approved, the pill could offer a more convenient alternative to Abbott Laboratories Inc’s $8 billion-a-year injectable medication Humira.
The FDA now views the additional analysis as a major amendment to Pfizer’s application for approval, and set a new Nov. 21 deadline for reviewing the drug, the company said on Tuesday. It did not give more details of the data analysis it provided.
Pfizer said it still believes trial results favor the drug’s use, and is working with the FDA, as well as regulators in Europe, Japan and other countries, to bring it to market.
