Pfizer, AstraZeneca Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Pfizer and AstraZeneca.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, March 7, 2017 to Tuesday, March 13, 2017.
FDA Advisory Committee Recommends New Use for Pfizer’s Arthritis Drug Xeljanz
The US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) has recommended approval of a new use for Pfizer’s Xeljanz (tofacitinib), an arthritis drug. The supplemental new drug application (sNDA) for Xeljanz is under review by the FDA for treating adult patients with moderately to severely active ulcerative colitis (UC).
Xeljanz/Xeljanz XR is a Janus kinase inhibitor indicated now indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). The drug is also indicated for treating adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs.
The FDA’s decision on whether or not to approve tofacitinib for UC is expected by the Prescription Drug User Fee Act date in June 2018.
EMA Accepts Application for New Use of AstraZeneca’s Diabetes Drug Forxiga
The European Medicines Agency has accepted AstraZeneca’s marketing authorization variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with Type I diabetes.
Forxiga is a first-in-class selective inhibitor of human sodium-glucose co-transporter 2 (SGLT-2 inhibitor) indicated as both a monotherapy and as part of combination therapy to improve glycemic control, with the added effect of blood-pressure reductions and weight loss in adult patients with Type II diabetes.