Biohaven Pharmaceutical Holding Company Ltd. ndi Pfizer Inc. lero alengeza kuti Committee for Medicinal Products for Human Use (CHMP) ya European Medicines Agency (EMA) yatengera malingaliro abwino a rimegepant, calcitonin gene-related peptide (CGRP) receptor antagonist. , akulimbikitsa mlingo wa 75 mg wa rimegepant (omwe akupezeka ngati piritsi losungunula pakamwa) kuti avomereze malonda pa chithandizo chaching'ono cha migraine kapena opanda aura mwa akuluakulu komanso chithandizo chodzitetezera cha episodic migraine mwa akuluakulu omwe amadwala mutu waching'alang'ala kanayi pamwezi. .
Malingaliro abwino a CHMP tsopano adzawunikiridwa ndi European Commission (EC). Chigamulo chovomereza rimegepant, yemwe dzina lake la malonda la European Union (EU) lidzakhala VYDURA™, chidzapangidwa ndi EC ndipo chidzakhala chovomerezeka m'mayiko onse 27 omwe ali m'bungwe la EU komanso ku Iceland, Lichtenstein, ndi Norway. Ngati avomerezedwa, rimegepant adzakhala woyamba pakamwa CGRP receptor antagonist ku EU, ndi mankhwala a migraine okhawo omwe amavomerezedwa kuti azichiza pachimake komanso kupewa.
"Chidziwitso ichi cha chidaliro mu rimegepant chimatifikitsa kufupi ndi cholinga chathu chothandizira odwala omwe ali ndi matenda a ubongo ofowoketsa kuti apeze chithandizo choyenera," anatero Nick Lagunowich, Purezidenti wa Global, Pfizer Internal Medicine. "Pfizer amanyadira kukhala ndi phazi lamphamvu ku Europe, zomwe zingathandize kubweretsa njira yatsopanoyi yothandizira anthu mamiliyoni ambiri ku Europe omwe ali ndi migraine."
Lingaliro labwino la CHMP lidachokera pakuwunikanso zotsatira kuchokera ku maphunziro atatu a Phase 3 komanso kafukufuku wanthawi yayitali, wotseguka wachitetezo pamankhwala owopsa a migraine, komanso kafukufuku wa Phase 3 wokhala ndi 1-year open-label extension mu kupewa chithandizo cha mutu waching'alang'ala. M'maphunzirowa, rimegepant inali yotetezeka komanso yololera bwino ndi mitengo ya zochitika zoyipa zofanana ndi za placebo.
"Malangizo a rimegepant ndi ofunika kwambiri kwa anthu a migraine," adatero Vlad Coric, MD, Chief Executive Officer ndi Chairman wa Board of Biohaven. "Pamodzi ndi Pfizer, tadzipereka kuthandiza odwala ndipo tikuyembekeza kupereka chithandizo kwa odwala ku Ulaya posachedwa, ndipo pamapeto pake padziko lonse lapansi, omwe ali ndi matendawa, ambiri mwa iwo alibe njira zokhutiritsa za chithandizo masiku ano."
ZOMWE MUNGACHITE PA NKHANIYI:
- today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, recommending the 75 mg dose of rimegepant (available as an orally dissolving tablet) for marketing authorization for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month.
- The CHMP positive opinion was based on the review of the results from three Phase 3 studies and a long-term, open-label safety study in acute treatment of migraine, and a Phase 3 study with a 1-year open-label extension in the preventive treatment of migraine.
- The decision on whether to approve rimegepant, whose European Union (EU) trade name will be VYDURA™, will be made by the EC and would be valid in all 27 EU member states as well as in Iceland, Lichtenstein, and Norway.
