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Home Pfizer and Biohaven Receive Positive CHMP Opinion for Rimegepant as First Dual-Use Oral CGRP Antagonist for Migraine Acute and Preventive Treatment in EU

Pfizer and Biohaven Receive Positive CHMP Opinion for Rimegepant as First Dual-Use Oral CGRP Antagonist for Migraine Acute and Preventive Treatment in EU

Feb 26, 2022 00:18 CST Updated 00:18
Biohaven

Biopharmaceutical Manufacturer

Pfizer

Pharmaceutical R&D Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


News on February 25, 2022 /BioValleyBIOON/ --Biohaven Pharmaceutical andPfizer(Pfizer) recently announced jointly that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive review opinion, recommending the approval of rimegepant (75mg, orally disintegrating tablet): (1)For the acute treatment of adult migraine (with or without aura)；（2）For the preventive treatment of episodic migraine (EM) in adults with at least 4 migraine attacks per month.

Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within 2 months.If approved, rimegepant will become the first and only oral CGRP receptor antagonist in the EU that can be used for both acute treatment and preventive treatment of migraine.In the EU, rimegepant will be marketed under the brand name Vydura.

The positive review opinion of the CHMP is based on the results of three Phase 3 studies and one long-term open-label safety study conducted for the acute treatment of migraine, as well as one Phase 3 study (with a 1-year open-label extension) for preventive treatment of migraine. In these studies, rimegepant was safe and well-tolerated, with an incidence of adverse events similar to that of placebo.

According to the terms of the collaboration agreement between Biohaven and Pfizer earlier this year, Pfizer has commercial rights to rimegepant outside the U.S. market. Biohaven continues to lead global R&D and retains the rights in the U.S. market.

Chemical Structure of Rimegepant

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that treats the root cause of migraines by reversibly blocking the CGRP receptor and inhibiting the biological activity of the CGRP neuropeptide. CGRP and its receptor are expressed in neurological regions associated with the pathophysiology of migraines and have become a popular target for migraine drug development.

Rimegepant targets a key component of migraine by reversibly blocking the CGRP receptor, thereby inhibiting the biological cascade that leads to migraine attacks.A single 75mg fast-dissolving tablet of rimegepant can provide rapid pain relief, significant pain reduction, and restoration of normal function, with lasting effects of up to 48 hours for many patients. Rimegepant can be taken orally as needed, up to 18 doses per month, to stop migraine attacks, or once every other day to help prevent migraine attacks and reduce the number of migraine days per month.。rimegepantNon-addictive, inClinical TrialNot related to medication-overuse headache or rebound headache.

In the United States, Nurtec ODT (rimegepant, 75mg) was first approved in February 2020 for the acute treatment of migraine (with or without aura) in adults, regardless of the number of migraine days per month. In May 2021, Nurtec ODT received approval for a new indication: preventive treatment of migraine, applicable to adult patients with episodic migraine (EM) who experience fewer than 15 headache days per month. Additionally, the approved product label has been expanded to include the use of up to 18 doses of Nurtec ODT 75mg per month, allowing for both acute and preventive treatment in the same patient.

It is worth mentioning that,Nurtec ODT is the first orally administered CGRP antagonist approved for the preventive treatment of migraine, and it is also the first orally administered CGRP receptor antagonist approved for both acute and preventive treatment of migraine in adults.This approval marks an important advancement in the care of hundreds of millions of migraine patients worldwide: for the first time, a drug can be used simultaneously to treat and prevent migraine attacks.

Nurtec ODT is the first and only one approved by the United StatesFDAApproved Fast-Acting Oral Disintegrating Tablet (ODT) Formulation of CGRP Receptor Antagonist. The medication can disperse instantly in the mouth without water, making it highly convenient to take anytime, anywhere.

Nurtec ODT Offers a More Comprehensive and Flexible Treatment Option: Recommended Dose is 75mg, Allowing Migraine Patients to Better Control Their Condition. A Single Dose of Nurtec ODT Can Quickly Relieve Pain and Provide Sustained Relief for up to 48 Hours in Many Patients. Nurtec ODT Can Be Taken Once Daily as Needed to Stop a Migraine Attack or Every Other Day to Help Prevent Migraines and Reduce Monthly Migraine Days. (Bioon.com)