GSK, Valeant receive FDA approval for Potiga
RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.
The FDA approved Potiga (ezogabine) tablets for the treatment of partial-onset seizures in patients ages 18 years and older.
“We are so pleased to reach such an important milestone with the U.S. approval of Potiga by the FDA,” Valeant head of research and development Susan Hall said. “We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications.”
The FDA has recommended that the drug be scheduled as a controlled substance, and it won’t be available until the Drug Enforcement Administration makes a final decision on how to classify it, but the drug makers said they expected that to happen by the end of the year.
Merck, Hanwha to develop Enbrel biosimilar
WHITEHOUSE STATION, N.J. — Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.
Merck, which operates outside the United States and Canada as MSD to avoid confusion with Germany-based Merck KGaA, announced Monday a collaboration with Seoul, South Korea-based Hanwha Chemical to develop and commercialize HD203, a biosimilar version of Enbrel (etanercept), made by Amgen and Pfizer. The drug is used to treat such disorders as rheumatoid arthritis and psoriasis.
Under the agreement, Hanwha’s Bio Business Unit and a Merck subsidiary will work on the biosimilar, developed by Hanwha. Merck will be responsible for clinical development and manufacturing and will commercialize the drug in markets around the world, except Korea and Turkey, where Hanwha has marketing rights. Financial terms were not disclosed, but the companies said they will involve upfront commercial payments and potential milestones and royalties for Hanwha.
“This collaboration to develop and commercialize our lead biosimilar candidate with a leading global healthcare company such as Merck represents a significant event both strategically and financially for Hanwha, and underscores the success of our biopharmaceutical strategy,” Hanwha CEO K.J. Hong said. “We are excited and proud that Hanwha’s biobusiness is now well-positioned to make a major contribution toward providing access to a biosimilar form of one of the world’s leading biologic therapies.”
Merck revises labels for 16 drugs
SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.
Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.
“We commend Merck for their efforts,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “This was no small undertaking, and we are hopeful that Merck’s new standardized labels will aid in reducing pharmacy selection errors.”
The project included evaluating proposed label content and layout, selecting new packaging design and getting approval from the FDA.