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FDA Accepts Biohaven's (BHVN) sNDA for Migraine Drug Nurtec
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Biohaven Pharmaceutical (BHVN - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for its migraine drug Nurtec ODT (rimegepant). The sNDA is seeking a label expansion of the drug to include preventive treatment of migraine. A decision on the sNDA from the FDA is expected in the second quarter of 2021.
Notably, Nurtec ODT was approved as an acute treatment of migraine in February. It will be the first and the only drug indicated for treating acute episodes of migraine attacks as well as prevention of future occurrences of migraine, if the sNDA is approved.
Shares of Biohaven have gained 41.2% so far this year compared with the industry’s increase of 3.1%.
The sNDA filed included data from the pivotal study — Study 305 — evaluating Nurtec ODT as a migraine preventive treatment. The regulatory filing also included data from an open label safety study, which supported the drug’s approval as an acute treatment of migraine.
Patients in the pivotal study received a 75mg dose of Nurtec ODT. Data from the study showed that the treatment achieved statistically significant reduction in monthly migraine days during the third month of treatment from the baseline versus placebo. Patients treated with Nurtec experienced a 4.3 days’ reduction from the baseline in monthly migraine days compared with 3.5 days for placebo. Moreover, a greater proportion of patients in the Nurtec arm achieved at least 50% reduction from the baseline in the mean number of moderate-to-severe migraine days per month compared to placebo.
The drug was launched as an acute treatment of migraine in March. It recorded $10.9 million worth of sales in the first half of 2020. A potential label expansion as a preventive migraine treatment next year will further boost the drug’s sales.
It is important to note that Nurtec competes with other CGRP-targeted drugs including Teva’s (TEVA - Free Report) Ajovy, Lilly’s (LLY - Free Report) Emaglity, AbbVie’s (ABBV - Free Report) Ubrelvy and Amgen’s Aimovig. While Ajovy, Emaglity and Aimovig are injected, Ubrelvy and Nurtec are available for oral administration.
Apart from migraine, Biohaven is evaluating Nurtec as a potential treatment of trigeminal neuralgia in a phase II study. Meanwhile, the company is developing another CGRP antagonist zavegepant for the acute treatment of migraine as well as for non-migraine indications. The company’s other key candidates include troriluzole, which is being developed for treating ataxias, Alzheimer’s disease and obsessive compulsive disorder, and verdiperstat, which is being evaluated in patients with multiple system atrophy or amyotrophic lateral sclerosis.
Biohaven Pharmaceutical Holding Company Ltd. Price
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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FDA Accepts Biohaven's (BHVN) sNDA for Migraine Drug Nurtec
Biohaven Pharmaceutical (BHVN - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for its migraine drug Nurtec ODT (rimegepant). The sNDA is seeking a label expansion of the drug to include preventive treatment of migraine. A decision on the sNDA from the FDA is expected in the second quarter of 2021.
Notably, Nurtec ODT was approved as an acute treatment of migraine in February. It will be the first and the only drug indicated for treating acute episodes of migraine attacks as well as prevention of future occurrences of migraine, if the sNDA is approved.
Shares of Biohaven have gained 41.2% so far this year compared with the industry’s increase of 3.1%.
The sNDA filed included data from the pivotal study — Study 305 — evaluating Nurtec ODT as a migraine preventive treatment. The regulatory filing also included data from an open label safety study, which supported the drug’s approval as an acute treatment of migraine.
Patients in the pivotal study received a 75mg dose of Nurtec ODT. Data from the study showed that the treatment achieved statistically significant reduction in monthly migraine days during the third month of treatment from the baseline versus placebo. Patients treated with Nurtec experienced a 4.3 days’ reduction from the baseline in monthly migraine days compared with 3.5 days for placebo. Moreover, a greater proportion of patients in the Nurtec arm achieved at least 50% reduction from the baseline in the mean number of moderate-to-severe migraine days per month compared to placebo.
The drug was launched as an acute treatment of migraine in March. It recorded $10.9 million worth of sales in the first half of 2020. A potential label expansion as a preventive migraine treatment next year will further boost the drug’s sales.
It is important to note that Nurtec competes with other CGRP-targeted drugs including Teva’s (TEVA - Free Report) Ajovy, Lilly’s (LLY - Free Report) Emaglity, AbbVie’s (ABBV - Free Report) Ubrelvy and Amgen’s Aimovig. While Ajovy, Emaglity and Aimovig are injected, Ubrelvy and Nurtec are available for oral administration.
Apart from migraine, Biohaven is evaluating Nurtec as a potential treatment of trigeminal neuralgia in a phase II study. Meanwhile, the company is developing another CGRP antagonist zavegepant for the acute treatment of migraine as well as for non-migraine indications. The company’s other key candidates include troriluzole, which is being developed for treating ataxias, Alzheimer’s disease and obsessive compulsive disorder, and verdiperstat, which is being evaluated in patients with multiple system atrophy or amyotrophic lateral sclerosis.
Biohaven Pharmaceutical Holding Company Ltd. Price
Biohaven Pharmaceutical Holding Company Ltd. price | Biohaven Pharmaceutical Holding Company Ltd. Quote
Zacks Rank
Biohaven currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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