Pfizer Inc. (NYSE:PFE) Gets FDA Approval On New Drug Label


Dallas, Texas 02/27/2014 (FINANCIALSTRENDS) – Drug maker Pfizer Inc. (NYSE:PFE) disclosed on 24th February that it has received U.S Food and drug administration’s approval to append additional data it had collected with respect to radiographic tests it had conducted to track and quantify the recovery seen in joint damage in its adult patient candidates who were treated by its target drug “XELJANZ® (tofacitinib citrate)”. The data is expected to help the drug maker in getting approval for a more impressive and all accommodating Label for commercialization. The approval will help the drug maker market its Xelianz drug with a new label which would include data from its phase 3 clinical tests.

Commenting about the approval for submitting a new drug application, Dr. Steven Romano, who is the lead for the tests conducted by “Pfizer Global Innovative Pharmaceutical Practice”, has been quoted to have said that, “XELJANZ is the first oral JAK inhibitor for moderately to severely active rheumatoid arthritis. The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinically meaningful outcome for patients.

If the new label approved, allows the target drug XELJANZ to be used in association with other arthritis drugs in order to treat the patient with the intention of reducing pain. The new label will prominently feature the data which was collected by the drug maker from its radiographic tests which would compare the effect of the treatment after a 6 month and a 12 month treatment time frame. The drug maker had found that the joint damage which was measured in terms of globally recognized “in van der Heijde modified Total Sharp Score (mTSS)” metric had significantly reduced in the 12 month time frame.

The latest development goes on to prove that the drug maker Pfizer Inc. (NYSE:PFE) is well equipped to maximize its returns from its existing R&D investments in approved drugs.