Baxter International Inc. (NYSE:BAX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for extension of the therapeutic indications of KIOVIG to include a new indication for multifocal motor neuropathy (MMN), a severe, debilitating disorder requiring lifelong treatment. With adoption by the European Commission, Baxter will receive marketing authorization for KIOVIG MMN indication in all European Union (EU) Member States- the first centrally-licensed indication for an immunoglobulin preparation for MMN.
MMN is a rare autoimmune disorder characterized by progressive weakness in the limbs, leading to significant difficulty with simple manual tasks. If left untreated, MMN often progresses to more severe weakness, including muscle atrophy or involuntary twitching.
"With today's CHMP recommendation, Baxter looks forward to offering patients suffering from MMN a licensed treatment option to relieve their symptoms of limb weakness and motor dysfunction," said Professor Hartmut Ehrlich, vice president, global research and development for Baxter's BioScience business. "Baxter remains committed to building upon its long history and proven experience with IVIG therapy to advance treatment in targeted neurological disorders, such as MMN."
The KIOVIG MMN CHMP positive opinion is based on two prospective, open label, investigator initiated clinical efficacy studies in patients with MMN, both showing maintenance of muscle strength and improved functionality. Adverse events were reversible and consistent with those seen in other KIOVIG indications, with no serious adverse events.
"MMN is a debilitating auto-immune disorder that affects individuals' limb strength and motor skills at the prime age of their lives, requiring life-long treatment," said Leonard van den Berg, MD, PhD, Professor in Neurology at the University Medical Center, Utrecht, The Netherlands. "IVIG therapy has long been recognised as recommended therapy for MMN. However, due to the rarity of this disorder the availability of efficacy data and treatment options for MMN remain low despite years of research. An EU-wide approval will mark an important new opportunity for physicians to improve the lives of patients suffering from MMN."
KIOVIG is also the only IVIG treatment offered in a 30 gram vial. This larger vial size offers added convenience of dosing for patients requiring larger doses of IVIG treatment.
Baxter International Inc.,