Breaking News
April 20, 2019 - Texas A&M AgriLife becomes the newest member of NutriRECS international consortium
April 20, 2019 - In most states, insurance won’t cover addiction treatments
April 20, 2019 - Computer-based memory games may be beneficial for individuals with fragile X syndrome
April 20, 2019 - Timing of food intake influences molecular clock in the liver of mice
April 20, 2019 - Precise decoding of breast cancer cells paves way for new treatment option
April 20, 2019 - Scientists use 3D imaging to help model complex processes performed by placenta
April 20, 2019 - MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS
April 20, 2019 - Genetic variants that protect against obesity could aid new weight loss medicines
April 20, 2019 - New technology developed for microscopic imaging in living organisms
April 20, 2019 - when quitting cigarettes, consider using more nicotine, not less
April 20, 2019 - Key proteins can block Listeria without triggering the death of host cells
April 20, 2019 - Researchers create a working model of cerebral tract to study brain function
April 20, 2019 - New study shows that microbes can help break toxic chemical in dust
April 20, 2019 - Scientists use NIR light and injected DNA nanodevice to guide stem cells to injury
April 20, 2019 - Microbial Features ID’d for Pediatric Irritable Bowel Syndrome
April 20, 2019 - Study reveals patterns of drug intoxication deaths, organ donors across the US
April 20, 2019 - Scientists deploy CRISPR gene-editing tool to engineer multiple edits
April 20, 2019 - AHA News: Here’s How Middle-Aged People — Especially Women — Can Avoid a Heart Attack
April 20, 2019 - Charcot foot: MedlinePlus Medical Encyclopedia
April 20, 2019 - France to ban popular breast implants over cancer risk: media
April 20, 2019 - Researchers explore whether time of day can affect the body’s response to physical exertion
April 20, 2019 - CPAP brings longer life for obese people with sleep apnea: Study
April 20, 2019 - New discovery transforms conventional microfluidics into open-space microfluidics
April 20, 2019 - An accurate estimation of the overall cost of bacterial resistance in French hospitals during 2015 and 2016
April 20, 2019 - ‘PRO-cision Medicine’ approach helps personalize care for patients with cancer
April 19, 2019 - TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
April 19, 2019 - Screen time—even before bed—has little impact on teen well-being: study
April 19, 2019 - Cytosurge’s first FluidFM User Conference
April 19, 2019 - New study finds that previously described differences among endoscopists are not true
April 19, 2019 - Study compares effectiveness and cost of gene therapy and HSCT in major beta-thalassemia
April 19, 2019 - Scientific breakthrough provides new hope for people living with multiple sclerosis
April 19, 2019 - New Virtual Reality Therapy game could offer relief for patients with chronic pain, mobility issues
April 19, 2019 - Emergency medicine doctors find better way to treat severe epileptic seizures in children
April 19, 2019 - MedlinePlus: Cholesterol Good and Bad
April 19, 2019 - For busy medical students, two-hour meditation study may be as beneficial as longer course
April 19, 2019 - Music therapy helps young patients feel better
April 19, 2019 - Molecular target UNC45A is essential for cancer cell proliferation and tumor growth
April 19, 2019 - Crackling and wheezing could be the sounds of a progressing lung disease
April 19, 2019 - Key research takeaways from ECCMID 2019
April 19, 2019 - AI Can Identify Model of Cardiac Rhythm Device From Chest X-Ray
April 19, 2019 - New way to combat childhood anxiety: treat the parents
April 19, 2019 - Women getting C-sections best judge of own pain medication needs | News Center
April 19, 2019 - Light-intensity physical activity associated with healthy brain aging
April 19, 2019 - Immune responses that prevent fungal infections may eliminate Trichinella spiralis
April 19, 2019 - Exercising in the morning, rather than at night, may yield better results, shows study
April 19, 2019 - Why eating ‘right’ could cause you to stray from your diet
April 19, 2019 - Health Tip: Antidepressant Precautions – Drugs.com MedNews
April 19, 2019 - Bigger portions lead to preschoolers eating more over time
April 19, 2019 - Specific strains of Staphylococcus aureus linked to wounds that do not heal
April 19, 2019 - Morning exercise may burn more calories
April 19, 2019 - Revolutionary discovery paves new way for treatment of necrotizing enterocolitis
April 19, 2019 - Drug that treats high blood pressure shows promise against neurodegenerative diseases
April 19, 2019 - More care is needed for patients after kidney transplantations, reports research
April 19, 2019 - Virtual reality offers benefits for Parkinson’s disease patients
April 19, 2019 - Liver Illness Strikes Latino Children Like A ‘Silent Tsunami’
April 19, 2019 - Disruptive behaviors in autistic children linked to reduced brain connectivity
April 19, 2019 - New insights into how vitamin D affects immune system
April 19, 2019 - Research sheds light on how hepatitis B virus establishes chronic infection
April 19, 2019 - New scoring system based on genetic markers predicts obesity risk at birth
April 19, 2019 - Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
April 19, 2019 - Exercise can improve non-motor symptoms of Parkinson’s disease
April 19, 2019 - Phasefocus to launch new cell imaging system
April 19, 2019 - KZFPs play a key role in the regulation of human genome
April 19, 2019 - DWK Life Sciences offers Workflow Solutions to improve productivity
April 19, 2019 - Bedfont wins 2nd accolade at the South East FSB Awards 2019
April 19, 2019 - Extracts of ginkgo seeds show antibacterial activity on pathogens that cause skin infections
April 19, 2019 - Groundbreaking experiment in pigs challenges the notion about brain damage
April 19, 2019 - Improving the quality of digital pathology imaging
April 19, 2019 - Scientists get closer to injecting artificial lymph nodes into people to fight disease
April 19, 2019 - Exercises and swimming goggles may reduce adverse effects on eye during long spaceflights
April 19, 2019 - Review suggests a reciprocal relationship between obesity and self-control
April 19, 2019 - Synthetic biologists add analog-to-digital signal processing to genetic circuitry of living cells
April 19, 2019 - Study identifies how enterococci bacteria cause antibiotic-resistant bloodstream infections
April 19, 2019 - Triple negative breast cancer develop resistance to chemotherapy by turning on molecular pathway
April 19, 2019 - Researchers identify key clues to brain and pancreas development
April 19, 2019 - Metformin May Cut Risk for Prematurity, Miscarriage in PCOS
April 19, 2019 - Obese mouse mothers trigger heart problems in offspring
April 19, 2019 - Research sheds light on how leukemia cells become resistant to drugs
April 19, 2019 - Health Tip: Stopping Nosebleeds – Drugs.com MedNews
April 19, 2019 - Pediatric endocrinologist gives iconic ‘Mona Lisa’ a second medical opinion
Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant

Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant

image_pdfDownload PDFimage_print

NEW HAVEN, Conn., March 13, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the Company concluded its pre-New Drug Application (“NDA”) meetings with the U.S. Food and Drug Administration (“FDA”) for rimegepant Zydis® ODT (orally dissolving tablet) and tablet formulations for the acute treatment of migraine. The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements for the Company’s NDA submission.

Biohaven submitted a pre-NDA briefing document to the FDA that outlined the Company’s preliminary data package being prepared for the NDA submission, including clinical safety and efficacy, non-clinical results, CMC and other regulatory elements. Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient for submission, with acceptance of the final NDA subject to the FDA’s review of the complete filing.

“Based upon Biohaven’s in-person meeting and written communications with FDA regarding our pre-NDA briefing package, we believe that all the components of our upcoming rimegepant NDA are well positioned to fulfill the FDA’s requirements for submission,” said Vlad Coric, M.D, Chief Executive Officer of Biohaven. “Biohaven is excited to advance our development program to an NDA submission in the second quarter of 2019 and highlight the previously announced positive data from three pivotal Phase 3 trials and safety data from our ongoing long-term safety study. We look forward to working with the FDA to bring this much-needed, novel and differentiated treatment option to patients suffering from migraine.”

Biohaven announced positive topline results from a randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the efficacy and safety of its Zydis ODT formulation of rimegepant in December of 2018. In this trial, rimegepant Zydis ODT was statistically superior to placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures pre-specified in hierarchical testing. Importantly, patients treated with the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes after dosing, and this difference was statistically significant at 60 minutes (p < 0.0001). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p = 0.0025).  Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.0001), pain relief (p < 0.0001), freedom from the most bothersome symptom (p = 0.0018), and freedom from functional disability (p < 0.0001). The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.

The Company also announced initial positive results from its ongoing long-term, open-label safety study of rimegepant (Study 201) for the acute treatment of migraine in December 2018; over 91,000 doses of rimegepant 75 mg were administered across 1,780 patients with migraine. The safety and tolerability profile of rimegepant with up to one year of dosing in patients with migraine was consistent with previous clinical experience. No liver safety signal was detected, including a subset of patients with near-daily dosing (≥15 doses/month), as assessed by an external independent panel of liver experts. In addition to the interim safety analysis, preliminary open-label efficacy data from Study 201 suggest that rimegepant may be associated with a reduction in migraine days per month compared to the observational lead-in period, suggesting a potential preventive effect.  A double-blind, placebo-controlled Phase 3 trial examining regularly scheduled dosing of rimegepant 75 mg for the preventive treatment of migraine is ongoing and the Company expects to report topline data from this trial in 2019.

In March of 2018, the Company announced successful achievement of co-primary regulatory endpoints along with key secondary outcome measures in two pivotal Phase 3 trials of rimegepant. In each trial, rimegepant 75 mg met the co-primary efficacy endpoints of superiority to placebo at two hours post-dose on the measures of pain freedom and freedom from the most bothersome symptom. In both trials, rimegepant demonstrated a safety and tolerability profile similar to placebo, including on liver function tests.

About Rimegepant

Rimegepant is Biohaven’s orally-dosed CGRP receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the  FDA and provide the basis for a planned submission of an NDA in the second quarter of 2019.

About Biohaven

Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxide inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release regarding the Company’s business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing of the Company’s planned NDA submission for rimegepant, the outcome of expected regulatory filings, the timing and results of the Company’s planned and ongoing clinical trials and the potential commercialization of the Company’s product candidates. The use of certain words, including “believe”, “continue”, “may”, “on track”, “expects” and “will” and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

Posted: March 2019

Tagged with:

About author

Related Articles