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Ervebo, First vaccine to protect against Ebola
19 November 2019
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus. “This is an important…
Baqsimi (glucagon), first non-injectable treatment for severe low blood sugar levels
12 November 2019
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Baqsimi (glucagon), the first treatment for severe hypoglycaemia (low blood sugar levels) that can be administered without an injection to patients with diabetes aged four years and…
Reyvow (lasmiditan), new treatment for patients with migraine
5 November 2019
The U.S. Food and Drug Administration has approved Reyvow (lasmiditan) tablets for the acute (active but short-term) 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. “Reyvow is a new…
Trikafta (elexacaftor/ivacaftor/tezacaftor), new breakthrough therapy for cystic fibrosis
4 November 2019
The U.S. Food and Drug Administration has approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least…
Mavyret (glecaprevir and pibrentasvir), a treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis, shortens the duration of treatment to eight weeks
1 October 2019
Mavyret (glecaprevir and pibrentasvir) tablets, have now been approved by the FDA for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated…
Rybelsus (semaglutide), first oral GLP-1 treatment for type 2 diabetes
24 September 2019
The U.S. Food and Drug Administration has approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the…
Ofev (nintedanib), first treatment for patients with rare type of lung disease
23 September 2019
The U.S. Food and Drug Administration has approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung…
Nourianz (istradefylline), new add-on drug to treat off episodes in adults with Parkinson’s disease
7 September 2019
The U.S. Food and Drug Administration has approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an…
Xenleta (lefamulin), new antibiotic to treat community-acquired bacterial pneumonia
31 August 2019
The U.S. Food and Drug Administration has approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, M.D., M.P.H.,…