The U.S. FDA has reportedly approved Pfizer’s XELJANZ drug – also called tofacitinib for treating adult patients suffering from modest to serious active ulcerative colitis. Incidentally, the medicine had already been given a green signal by the FDA for treating patients affected due to psoriatic arthritis and rheumatoid arthritis.
Experts project that the drug will generate a revenue of nearly USD 2.16 billion in 2019. For the record, it had accrued revenue from sales worth USD 1.35 billion last year.
The federal agency of the U.S. approved the drug after observing the outcomes of three Phase 3 clinical drug tests performed on the patients suffering from ulcerative colitis. The results derived from two of the three trials displayed that XELJANZ had caused an ailment remission in nearly seventeen to eighteen percent of the subjects. Researchers believe that the drug approval is good news for patients suffering from ulcerative colitis as it will offer them a new oral treatment alternative.
The U.S. FDA has reported that over 900,000 of the U.S. populace are affected due to ulcerative colitis. According to Michael Goettler, Global President, Inflammation & Immunology at Pfizer Inc., since ulcerative colitis is a severe inflammatory bowel disorder with less therapeutic alternatives, FDA’s approval of the XELJANZ drug will help the adult patients undergo steroid-free treatment and remission.
However, Pfizer has cautioned the patients to avoid the consumption of the drug along with other biological treatments or intake of the medicine with immunosuppressants such as cyclosporine and azathioprine. Risks observed during the clinical drug trials were severe infections such as gastrointestinal perforation, herpes zoster, malignancies, and opportunistic infections. Hence, FDA has reportedly approved the 10-mg intake of XELJANZ® medicine two times a day for nearly 8 weeks.
Post the approval of the drug, Pfizer’s shares rose 1.1% at USD 36.11 in the afternoon trading.