Ariad, Endo, Lilly, and Teva Lead Drug Approvals
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Endo, Eli Lilly and Company, and Teva as well as Ariad Pharmaceuticals.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 30, 2016 to Tuesday December 6, 2016.
Ariad Gets FDA OK for Leukemia Drug
Ariad Pharmaceuticals was granted full approval by the US Food and Drug Administration for new indications for Iclusig (ponatinib), its anti-cancer drug.
The FDA approved the following new indications for Iclusig: treating adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML), or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and treating adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL.
Iclusig was initially approved in December 2012 under the FDA’s accelerated approval program for treating adult patients with chronic phase, accelerated phase, or blast phase CML that is resistant or intolerant to prior tyrosine kinase inhibitor therapy, or Ph+ALL that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Iclusig was also granted orphan drug designation by the FDA.
Source: Ariad Pharmaceuticals
Endo Launches Generic of Roche’s Organ-Transplant Drug
Endo International’s operating company, Par Pharmaceutical, has begun shipping its generic version of CellCept (mycophenolate mofetil hydrochloride), Roche’s organ-transplant drug, following final approval from the US Food and Drug Administration for its abbreviated new drug application for mycophenolate mofetil hydrochloride for injection.
Roche’s CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. US sales of injectable CellCept were approximately $42 million for the 12 months ended October 31, 2016, according to QuintilesIMS data and as cited by Endo.
Endo’s mycophenolate mofetil hydrochloride for injection product is packaged in cartons of four 500 mg single dose vials.
Source: Endo International
FDA OKs New Indication for Lilly’s Diabetes Drug
The US Food and Drug Administration (FDA) has approved a new indication for Eli Lilly and Company’s Jardiance (empagliflozin), a diabetes drug. The new indication is for reducing the risk of cardiovascular death in adults with Type 2 diabetes and established cardiovascular disease. Jardiance is marketed by Boehringer Ingelheim and Eli Lilly and Company. It was developed as part of the diabetes alliance formed between Boehringer Ingelheim and Eli Lilly in 2011.
In 2014, Jardiance was approved by the FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with Type 2 diabetes.
Source: Eli Lilly and Company
Teva Gets Favorable Label for Multiple Sclerosis Drug
Teva Pharmaceutical Industries has received a positive outcome in its European labeling for Copaxone (glatiramer acetate injection) 20 mg/mL, its multiple sclerosis drug. Through the variation procedure, a pregnancy contraindication was removed from the drug’s European label.
The removal of the pregnancy contraindication follows a positive variation assessment report issued by the UK’s Medicines and Healthcare Products Regulatory Agency and agreed by all Concerned Member States in Europe that were involved in the procedure. Granting of national approvals by all involved European Union member states will happen in the near future, Teva said.
Copaxone is indicated for treating patients with relapsing forms of multiple sclerosis. The Copaxone brand is approved in more than 50 countries worldwide, including the US, Russia, Canada, Mexico, Australia, Israel, and all European countries.
Source: Teva Pharmaceutical Industries