FDA has approved Reyvow, a new treatment for patients with migraine
The FDA ( U.S. Food and Drug Administration ) has approved Reyvow ( Lasmiditan ) tablets for the acute treatment of migraine with or without aura ( a sensory phenomenon or visual disturbance ) in adults.
Reyvow is not indicated for the preventive treatment of migraine.
Migraine headache pain is often described as an intense throbbing or pulsing pain in one area of the head.
Additional symptoms include nausea and/or vomiting and sensitivity to light and sound.
Approximately one-third of individuals who suffer from migraine also experience aura shortly before the migraine.
An aura can appear as flashing lights, zig-zag lines, or a temporary loss of vision.
Migraines can often be triggered by various factors including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet.
Migraine is three times more common in women than in men and affects more than 10% of people worldwide.
The effectiveness of Reyvow for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials.
A total of 3,177 adult patients with a history of migraine with and without aura treated a migraine attack with Reyvow in these studies.
In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom ( nausea, light sensitivity, or sound sensitivity ) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo.
Although patients were allowed to take a rescue medication two hours after taking Reyvow, opioids, barbiturates, triptans and ergots were not allowed within 24 hours of the study drug’s administration.
Twenty-two percent of patients were taking a preventive medication for migraine.
There is a risk of driving impairment while taking Reyvow. Patients are advised not to drive or operate machinery for at least eight hours after taking Reyvow, even if they feel well enough to do so. Patients who cannot follow this advice are advised not to take Reyvow.
The drug causes central nervous system ( CNS ) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.
The most common side effects that patients in the clinical trials reported were dizziness, fatigue, a burning or prickling sensation in the skin ( paresthesia ), and sedation. ( Xagena )
Source: FDA, 2019
FDA has approved Emgality, the first treatment for episodic cluster headache that reduces the frequency of attacks
The FDA ( U.S. Food and Drug Administration ) has approved Emgality ( Galcanezumab-gnlm; Galcanezumab ) solution for injection for...
The Food and Drug Administration ( FDA ) has approved Nubeqa ( Darolutamide ) for non-metastatic castration-resistant prostate cancer. Approval was...
Relapsed and refractory multiple myeloma: European Commission has approved Empliciti plus Pomalidomide and low-dose Dexamethasone
The European Commission ( EC ) has approved Empliciti ( Elotuzumab ) plus Pomalidomide and low-dose Dexamethasone ( EPd )...
Direct-acting antivirals reduce risk of premature mortality and liver cancer for patients with chronic hepatitis C
The first prospective, longitudinal study investigating treatment of chronic hepatitis C with direct-acting antivirals finds that the treatment is associated...
Satralizumab, an anti-IL-6 receptor monoclonal antibody, reduces relapse risk for neuromyelitis optica spectrum disorder
Full pivotal phase III SAkuraStar study results for Satralizumab as a monotherapy for neuromyelitis optica spectrum disorder ( NMOSD ),...
FDA has approved treatment for patients with endometrial carcinoma: Lenvima in combination with Keytruda
The FDA ( U.S. Food and Drug Administration ) has announced Project Orbis, an initiative of the FDA Oncology Center...
The European Commission has granted marketing authorization in the European Union ( EU ) for the precision oncology treatment Vitrakvi...
Adults and children with all genotypes of hepatitis C and compensated cirrhosis: Mavyret shortens duration of treatment to eight weeks, approved by FDA
The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir )...
FDA has approved Ofev, first treatment for patients with interstitial lung disease associated with systemic sclerosis or scleroderma
The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate...
Standard methods to detect NTRK fusions in daily practice and clinical research: ESMO recommendations
NTRK1, NTRK2 and NTRK3 fusions are present in a plethora of malignancies across different histologies. These fusions represent the most...