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
FDA has approved Ayvakit, the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors
The FDA ( U.S. Food and Drug Administration ) has approved Ayvakit ( Avapritinib ) for the treatment of adults...
European Commission has approved expanded use of Erleada for treatment of patients with metastatic hormone-sensitive prostate cancer
The European Commission ( EC ) has granted marketing authorisation for the expanded use of Erleada ( Apalutamide ) to...
Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies
The coronavirus disease 2019 ( COVID-19 ) virus, emerged in December 2019, has spread rapidly, with cases now confirmed in...
The FDA ( U.S. Food and Drug Administration ) has approved Isturisa ( Osilodrostat ) oral tablets for adults with...
COVID-19 can have fatal consequences for people with underlying cardiovascular disease and cause cardiac injury even in patients without underlying...
Ibrutinib treatment for first-line and relapsed / refractory chronic lymphocytic leukemia: final analysis of PCYC-1102 study
The safety and efficacy of Ibrutinib ( Imbruvica ), a once-daily Bruton's tyrosine kinase inhibitor, in chronic lymphocytic leukemia...
Opdivo plus Yervoy for patients with hepatocellular carcinoma previously treated with Sorafenib, FDA approved
Opdivo ( Nivolumab ) 1 mg/kg plus Yervoy ( Ipilimumab ) 3 mg/kg ( injections for intravenous use ) was...
First-line treatment of EGFR-mutated non-small cell lung cancer: concurrent Osimertinib plus Gefitinib
First-line treatment with an EGFR tyrosine kinase inhibitor ( TKI ) is standard of care for patients with EGFR-mutated non-small-cell...
Newly diagnosed primary central nervous system lymphoma: Ibrutinib-based combination therapy has exhibited therapeutic benefit
Ibrutinib ( Imbruvica ) has shown single-agent activity in relapse / refractory ( R/R ) primary central nervous system lymphoma...