Biohaven's Rare Disease Drug Set to Launch Following FDA Approval

Biohaven is preparing to launch Vyglxia, an oral drug for rare brain diseases, pending FDA approval between October and December. The company is ready to ship the drug on day one, with a patient hub, nurse managers, specialists, and a small sales team in place. Vyglxia would be the company's first commercial product since it sold its main revenue driver, Nurtec ODT, to Pfizer in 2022. The launch is expected to be much smaller and less costly than Nurtec's launch, with no direct competitors.

Biohaven Pharmaceuticals is gearing up for the potential launch of Vyglxia, an oral drug designed to treat rare brain diseases. Pending FDA approval, which is expected between October and December, the company is ready to ship the drug on day one. CEO Vlad Coric has confirmed that a patient hub, nurse managers, specialists, and a small sales team are in place to ensure a successful launch [1].

Vyglxia would mark Biohaven's first commercial product since the company sold its main revenue driver, Nurtec ODT, to Pfizer in 2022. The launch is anticipated to be smaller and less costly than Nurtec's debut, with no direct competitors in the market [1].

The company has been proactive in preparing for the Vyglxia launch. Biohaven has already enrolled around 400 patients through open-label and expanded access programs and plans to convert these patients upon the drug's approval. The sales team will focus on the roughly two dozen centers of excellence for spinocerebellar ataxia and another 70 facilities specialized in movement disorders, which cover the majority of the estimated 6,000 to 7,000 patients in the U.S. [1].

In addition to the U.S. launch, Biohaven is also pursuing approval in Europe. The company had initially pulled its marketing application due to concerns about regulatory classification but has since gathered more data and notified European regulators of its plans to refile [1].

Despite recent setbacks, such as the failure of BHV-7000 in a bipolar mania trial and the FDA's delay in deciding on the troriluzole filing, Biohaven's stock has seen a significant increase following an investment deal with Oberland Capital Management worth up to $600 million [2]. This funding is expected to help Biohaven navigate the regulatory landscape and prepare for the launch of Vyglxia.

References:
[1] https://www.cafepharma.com/category/news-tags/companies/biohaven
[2] https://www.fiercebiotech.com/biotech/biohaven-trashes-troriluzole-ocd-after-as