US approval for Lilly’s migraine treatment Reyvow

The FDA has approved Eli Lilly’s Reyvow (lasmiditan), the first and only medicine in a new class of acute treatment for migraine.

As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for Reyvow.

Consistent with the FDA’s guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of Reyvow were associated with less drug liking when compared to alprazolam, but more than placebo.

The recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of FDA approval, after which Reyvow will be available to patients in retail pharmacies.

The New Drug Application (NDA) for Reyvow included data from two Phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of Reyvow for the acute treatment of migraine in adults.

Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom at two hours following administration of Reyvow in comparison to placebo.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

AbCellera raises $105m to advance antibody drug discovery platform

AbCellera has closed a $105 million Series B financing to further advance its antibody drug discovery platform. The financing was led by OrbiMed and current...

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Gilead & Arcus partner to develop next-gen cancer immunotherapies

Gilead Sciences and Arcus Biosciences, an oncology-focused biopharma working to create best-in-class cancer therapeutics, have entered into a ten-year partnership to co-develop and co-commercialise...

Atomwise announces partnerships to tackle COVID-19

Atomwise, a San Fran company using AI for small molecule drug discovery, has announced it has fifteen research collaborations underway with leading global universities...

GSK secures additional biopharma capacity via Samsung Biologics partnership

GlaxoSmithKline (GSK) has secured additional manufacturing capacity for its biopharmaceutical portfolio by partnering with South Korea’s Samsung Biologics. As per the agreement, Samsung Biologics will...

Related news

Chimeron Bio & NCBID to develop COVID-19 vaccine

RNA therapeutics company, Chimeron Bio, and George Mason University’s National Center for Biodefense and Infectious Diseases (NCBID), will together develop a COVID-19 vaccine. The vaccine...

AbCellera raises $105m to advance antibody drug discovery platform

AbCellera has closed a $105 million Series B financing to further advance its antibody drug discovery platform. The financing was led by OrbiMed and current...

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Gilead & Arcus partner to develop next-gen cancer immunotherapies

Gilead Sciences and Arcus Biosciences, an oncology-focused biopharma working to create best-in-class cancer therapeutics, have entered into a ten-year partnership to co-develop and co-commercialise...