Issue link: https://www.e-digitaleditions.com/i/1199406
Tablets & Capsules January 2020 11 Trikafta (elexacaftor/ivacaftor/ tezacaftor), manufactured by Ver- tex Pharmaceuticals, Boston, MA, has become the first FDA-approved t r iple combinat ion the r apy for patients with the most common cys- tic fibrosis mutation. The treatment is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane con- ductance regulator gene. reassure drug developers who have previously been aver se to using novel excipients because of the risk of safet y concerns that could be raised during an FDA application review. All written and electronic comments and information must be submitted by February 3. Briefly noted… The FDA approved the use of Calquence (acalabrutinib) for first- line therapy in chronic lymphocytic leukemia and small cell lymphoma. T he t argeted d r u g therapy was developed and tested at the Ohio State Univer sit y Comprehensive Cancer Center—Arthur G. James C ancer Hospital and R ichard J. Solove Research Instit ute in col- laboration with Acerta Pharma, San Francisco, CA. The FDA also approved Xcopri (cenobamate tablets) to treat par- tial-onset seizures in adults. It is manufactured by SK Life Sciences, Paramus, NJ. G l e n m a r k P h a r m a c e u t i c a l s has been g ranted FDA approval for abiraterone acet ate. It is a generic version of Zytigam which is manufactured by Janssen Biotech, Horsham, PA. The FDA approved Talicia (ome- prazole magnesium, amoxicillin, and rifabutin) as a treatment for Helico- bacter pylori (H. pylori) infection in adults. It is the only rifabutin-based therapy approved for H. pylori and is designed to address the high resis- tance of H. pylori bacteria to current clarithromycin-based therapies. Tali- cia is manufactured by RedHill Bio- pharma, Tel-Aviv, Israel. T h e a g e n c y e x p a n d e d t h e approval of Mavyret (glecaprevir and pibrentasvir) as an eight-week treat- ment for adults and children 12 years and older who have chronic hepatitis C virus genotype 1-6 infection and compensated cirrhosis and have not been previously treated for HCV. Mavyret is the first eight-week treat- ment of its kind, as most treatments for this condition are 12 weeks or longer. It is manufactured by AbbVie, North Chicago, IL. The FDA granted Eli Lilly, Indi- anapolis, IN, approval for Reyvow (lasmiditan) for the acute treatment of migraine with or without aura in adults. The agency also approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. It is manufactured by AstraZeneca, Cambridge, UK.