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 treatment of episodic cluster headache in adults.
Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months.
The headaches are accompanied by symptoms that may include: bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Some people experience restlessness and agitation.
Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and three hours.
The effectiveness of Emgality for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared the drug to placebo in 106 patients.
The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the Emgality and placebo groups.
During the three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for patients on placebo.
There is a risk of hypersensitivity reactions with Emgality use. If a serious hypersensitivity reaction occurs, treatment should be discontinued.
Hypersensitivity reactions could occur days after administration and may be prolonged.
The most common side effect reported by participants in the clinical trials was injection site reactions.
Emgality is given by patient self-injection. It was first approved by the FDA in September 2018 for the preventive treatment of migraine in adults. ( Xagena )
Source: FDA, 2019
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...