Pfizer Inc. (PFE) declared recently that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). The CHMP’s opinion will now be sent to the European Commission (EC) for final decision. If approved, XELJANZ in combination with methotrexate (MTX) will be indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
“More than 2.9 million people are presently living with moderate to severe rheumatoid arthritis in Europe. Even with multiple therapeutic options, many of these people may not adequately respond to presently available treatments, counting methotrexate,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “The positive CHMP opinion for tofacitinib is an important milestone as we work to bring this new oral treatment option to people in the European Union living with moderate to severe active rheumatoid arthritis.”
The marketing authorisation application (MAA) included data from the Oral Rheumatoid Arthritis Phase 3 TriaLs (ORAL) global development program in RA. This program consisted of six accomplished clinical trials, ORAL Start, ORAL Solo, ORAL Standard, ORAL Sync, ORAL Scan, and ORAL Step, in addition to two open-label long-term extension (LTE) studies. At the time of the MAA submission, the ORAL development program had accumulated more than 19,000 patient-years of drug exposure in over 6,100 patients with follow-up observations of up to eight years in one of the LTE studies.
Tofacitinib is part of the Janus kinase (JAK) inhibitor class of medications. This will be a new class of medicines for the treatment of moderate to severe active RA in the EU.
Apricus Biosciences Inc (APRI) declared that Richard Pascoe, Chief Executive Officer, will present at the 19th Annual BIO CEO & Shareholder Conference on Tuesday, February 14, 2017, at 9:00 a.m. Eastern Time. The conference will be held at The Waldorf Astoria, New York, NY. Mr. Pascoe will provide an update on Vitaros®, the Company`s topical treatment for erectile dysfunction.
A live audio webcast of the presentation can be accessed via the Shareholder Relations section of the Company`s website at www.apricusbio.com. Please log in about 5-10 minutes before the event to ensure a timely connection. A replay of the webcast will be available for 30 days following the presentation.