FDA approves first and only medicine in a new class of acute treatment for migraine

15 Oct 2019

The approval of Eli Lilly's Reyvow represents the first new class of acute migraine treatment approved by the FDA in more than two decades.

Eli Lilly has announced that the FDA has approved Reyvow (lasmiditan), an oral medication for the acute treatment of migraine, with or without aura, in adults. Reyvow has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).

FDA approves first  and only medicine in a new class of acute treatment for migraine

"Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack. There is a substantial unmet need for new acute treatments for migraine, like Reyvow, which is why we are proud of this approval and Lilly's continuing contribution to the migraine community," said Gudarz Davar, vice president, neurology development, Lilly Bio-Medicines. "New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine."

Consistent with the FDA's guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of Revow 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 the FDA approval, after which Reyvow will be available to patients in retail pharmacies.

"As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating," said Jan Brandes, assistant clinical professor, Department of Neurology, Vanderbilt University. "With new science comes new hope. Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like REYVOW is an important development for physicians and the patients we treat."

The New Drug Application (NDA) for Reyvow included data from two Phase III 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 (MBS; patient selected from nausea, sensitivity to light, or sensitivity to sound) at two hours following administration of Reyvow in comparison to placebo. Treatment emergent adverse events were generally mild to moderate and the most frequent included dizziness, fatigue, paresthesia (tingling or numbing sensation on the skin), sedation (sleepiness or drowsiness), nausea and/or vomiting and muscle weakness.

The Reyvow Phase III development program, including the open-label GLADIATOR study, involved more than 4,000 patients and the treatment of more than 20,000 migraine attacks.

"For over 25 years, Lilly has been committed to helping people affected by disabling headache disorders, investigating more than a dozen different compounds," said Patrik Jonsson, senior vice president and president, Lilly Bio-Medicines. "The approval of Reyvow is an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens."

Read More

Related news

Recipharm launches new service to support companies with QC and analytical requirements

Recipharm launches new service to support companies with QC and analytical requirements

1 Nov 2019

Services including method development, method validation, and stability program design and implementation.

Read more 
Lonza’s Ibex solutions to support Genmab’s growing clinical portfolio

Lonza’s Ibex solutions to support Genmab’s growing clinical portfolio

14 Oct 2019

Company's Ibex Design planned to take Genmab’s pre-clinical candidates from gene to potential IND within 12 months.

Read more 
Funding to accelerate delivery of Univercells' vaccine portfolio

Funding to accelerate delivery of Univercells' vaccine portfolio

11 Oct 2019

European financing to support Univercells’ R&D investments to develop four essential and undersupplied global health vaccines to be produced at affordable prices, high quality and large volumes.

Read more 
Industrial-scale manufacture of therapeutic exosomes

Industrial-scale manufacture of therapeutic exosomes

10 Oct 2019

Coordinated purification process development service accelerates progress to clinical trials, and scale-up manufacturing.

Read more 
BASF and Biomillenia join forces in microbiome research to promote healthy skin

BASF and Biomillenia join forces in microbiome research to promote healthy skin

7 Oct 2019

Research aims to identify novel dermocosmetic active ingredients via unique microbiome-on-a-chip technology.

Read more 
Arctoris secures funding to advance novel robotic drug discovery platform

Arctoris secures funding to advance novel robotic drug discovery platform

1 Oct 2019

Platform will enable scientists and biotechnology entrepreneurs worldwide to make discoveries faster and more efficiently,

Read more 
Data on lead ADC demonstrates effective tumour regression

Data on lead ADC demonstrates effective tumour regression

1 Oct 2019

IKS01 shows marked anti-tumour efficacy in pre-clinical models of ovarian and lung cancer.

Read more 
Researchers develop less toxic anti-cancer drug

Researchers develop less toxic anti-cancer drug

24 Sep 2019

New drug works like a ‘magic bullet’ that is delivered directly to the mitochondria of cancer cells.

Read more 
EC approves its first plant-derived cannabis-based medicine

EC approves its first plant-derived cannabis-based medicine

24 Sep 2019

Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.

Read more 
Study demonstrates potential of blood test for early lung cancer detection

Study demonstrates potential of blood test for early lung cancer detection

16 Sep 2019

Ground-breaking trial demonstrates potential of blood test which harnesses the power of the immune system to reduce late detection of lung cancer.

Read more