The U.S. Food and Drug Administration recently gave the go-ahead to two new drugs, Xeljanz and Quillivant XR, to treat rheumatoid arthritis and Attention Deficit Hyperactivity Disorder, respectively, the manufacturing companies announced in separate statements.
In receiving the approval, Pfizer explained that Xeljanz is a twice-daily oral treatment for adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate, a prior treatment for the disabling disease.
“Xeljanz is an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease,” said Pfizer CEO Ian Read. “With its novel mechanism of action, the discovery and development of Xeljanz by Pfizer scientists reflects our commitment to R&D innovation and our dedication to bringing important and meaningful medicines to patients.”
Meanwhile, NextWave Pharmaceuticals, an emerging specialty pharmaceutical company, touted the FDA’s approval of Quillivant XR — the first once-daily, extended-release liquid methylphenidate available for patients with ADHD.
Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Las Vegas, who was an investigator in the Quillivant XR laboratory classroom study said the approval “fills a void that has long existed in the treatment of ADHD.”
“We routinely see the struggles of patients who have difficulty swallowing pills or capsules. Having the option of a once-daily liquid will help alleviate some of these issues while still providing the proven efficacy of methylphenidate for 12 hours after dosing,” she said.
Quillivant XR is expected to become available in pharmacies in January 2013.