Branded

SILVER SPRING, Md. — Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) has a new indication. The Food and Drug Administration on Wednesday approved the drug to treat adults with chronic graft versus host disease after one or more treatments have failed.

This approval makes Imbruvica the first FDA-approved treatment for the illness, which afflicts patients who have received hematopoietic stem cell transplantation to treat blood or bone marrow cancers. The illness occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug to treat adults with chronic hepatitis C virus genotypes 1-6. Mavyret, from AbbVie, was approved for HCV patients without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those on dialysis.

The FDA said that Mavyret is the first treatment of eight-week duration for all hepatitis C genotypes.

WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved a new indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor). The new indication is for use in more than 600 people with cystic fibrosis ages 2 years and older who have one of five residual function mutations.

WOONSOCKET, R.I. — CVS Health on Wednesday outlined its plan for formulary management in 2018, which includes the removal of 17 products from its Standard Control Formulary. The move is part of the company’s rigorous approach to formulary management that it began in 2012. Since starting this effort, the company said it will bring $13.4 billion in cumulative savings to its pharmacy benefits manager clients through 2018.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new, targeted treatment for patients with relapsed/refractory acute myeloid leukemia. Idhifa (enasidenib), from Celgene, was approved for use with the RealTime IDH2 Assay, used to detect specific mutations in the IDH2 gene in patients with acute myeloid leukemia.

DENVER — The first methotrexate oral solution approved by the Food and Drug Administration, Xatmep, is now available, manufacturer Silvergate Pharmaceuticals announced Monday. The drug, approved by the FDA in April, is indicated to treat acute lymphoblastic leukemia and manage polyarticular juvenile idiopathic arthritis in pediatric patients.