Vlad CoricMD, CEO of Biohaven, said, “We are committed to partnering with Genpharm to expand NURTEC ODT access to patients with migraine in the UAE. The expansion of NURTEC ODT to countries outside the US is an important step for patients suffering from migraines and pursuing our strategy of global brand expansion through major distribution agreements. “
One rapid release of NURTEC ODT can provide rapid pain relief and return patients to normal function within an hour, and deliver lasting efficacy lasting up to 2 days after a single dose for many patients. NURTEC ODT spreads almost instantly in a person’s mouth without the need for water, offering a convenient, covert way for people with migraine to take their medication anytime and anywhere they need it. NURTEC ODT is not indicated for immune treatment of migraine. Biohaven partnered with Genpharm to seek regulatory approval for the NURTEC ODT file in the UAE.
Kamel Ghammachi, Co – Founder and Chairman of Genpharm, said, “We are proud to announce that the UAE has issued a NURTEC ODT marketing license. This is in line with Genpharm ‘s mission to accelerate access to innovative and innovative medicines. for patients in the area. “
Mu NURTEC ODT
NURTEC® ODT (rimegepant) is the first calcitonin gene-associated peptide receptor antagonist (CGRP) available in a rapidly releasing ODT form approved by the U.S. Food and Drug Administration (US Food and Drug Administration) FDA) for the treatment of severe migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraine. NURTEC ODT is a CGRP receptor antagonist that works by reversibly inhibiting CGRP receptors, thereby inhibiting the biological activity of the neuropeptide CGRP. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once a day. For more information about NURTEC ODT, visit www.nurtec.com.
The most common side effect was nausea (2% in patients who received NURTEC ODT compared with 0.4% in patients who received placebo). Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate stimulants of CYP3A or P-gp or BCRP inhibitors. Avoid another dose of NURTEC ODT within 48 hours when administered with moderate inhibitors of CYP3A4.
Signal
NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults.
Restrictions on use
NURTEC ODT is not indicated for immune treatment of migraine.
Important safety information
Contraindications: Hypersensitivity to NURTEC ODT or any of its components.
Warnings and warnings: If a severe hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate treatment. Adverse reactions to hypersensitivity have included dyspnea and rash, and can occur days after administration.
Adverse responses: The most common side effect was nausea (2% in patients who received NURTEC ODT compared with 0.4% in patients who received placebo). Less than 1% of patients treated with NURTEC ODT had hypertension, including dyspnea and rash.
Drug interactions: Avoid concomitant administration of NURTEC ODT with strong CYP3A4 inhibitors, strong or moderate CYP3A stimulants or P-gp or BCRP inhibitors. Avoid another dose of NURTEC ODT within 48 hours when administered with moderate inhibitors of CYP3A4.
Use in special numbers:
- Fertile / breastfeeding: It is not known if NURTEC ODT can harm an unborn baby or if it goes into breast milk.
- Hepatic damage: Avoid the use of NURTEC ODT in people with severe hepatic impairment.
- Kidney damage: Avoid use in patients with end-stage kidney disease.
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You are encouraged to report prescription drug side effects to the FDA. Visit him www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4NURTEC.
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About Genpharm Services
Genpharm Services is a regional pharmaceutical company, based in Dubai Science Park (DSP), UAE, with operations across the Middle East and North Africa (MENA) area. Genpharm is the leading partner in the sector for multinational companies with therapeutic medicine, in specialized care and rare diseases. Working with evidence-based medicine and thanks to an established expert team, Genpharm provides MENA with market access strategies and sustainable commercial solutions. For more information, visit https://www.genpharmservices.com/
About Biohaven
Biohaven is a commercial-grade biopharmaceutical company with a package of innovative, best-in-class treatments to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s neuroinnovation package includes FDA-approved NURTEC ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late product candidates across three distinct mechanical platforms: CGRP receptor antagonism for acute treatment and immune to migraine; glutamate modeling for obsessive-compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia; and MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.
Statement looking forward
This press release contains forward-looking statements within the meaning of the Private Security Literature Reform Act 1995. The use of certain words, including “believe” , “Can” and “will” and similar phrases, intended to look forward to statements. These forward-looking statements pose significant risks and uncertainties, including statements based on current expectations and assumptions about Biohaven’s management of NURTEC ODT as tight treatment for patients with migraine. Forward-looking statements include those related to: Biohaven’s ability to efficiently commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, compliance with requirements relevant US regulation, expected timing, initiation and results of Biohaven planned and ongoing clinical trials. , interaction time and films designed with the FDA, expected timing and production of regulatory films, potential commercialization of Biohaven product candidates, the potential for Biohaven product applicants to be first-class or best in class remedies and efficacy and safety of Biohaven product candidates. A number of important factors may cause actual results or events to differ significantly from those that may have been attributed to or identified by our forward-looking statements. Additional important features to be considered in respect of forward-looking statements are set out in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. air March 1, 2021. The forward-looking statements are forward-looking from this date and Biohaven assumes no responsibility for updating any forward-looking statements, whether as a result of new information, future events or otherwise. , but as required by law.
NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.
Contact Biohaven
Dr. Vlad Coric
Chief Executive
[email protected]
SOURCE Biohaven Ltd. pharmaceutical property company.
