FDA accepts NDA for kidney failure medication
LEBANON, N.J. The Food and Drug Administration has accepted the last part of a new drug application for a drug to treat a disease that causes kidney failure.
Orphan Therapeutics and Ikaria Holdings announced Friday that the FDA had accepted the final section of its application for Lucassin (terlipressin), designed to treat hepatorenal syndrome Type 1, a disease that causes kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause, resulting in rapid kidney failure and, in 80% of patients, death within three months.
The FDA has given the drug orphan drug status and fast-track designation. The agency gives orphan status to drugs used to treat rare conditions. Ikaria acquired North American rights to Lucassin from Orphan in September.
Xenon, Merck team up for cardiovascular disease treatment research
Xenon announced its recent partnership with Merck and Co. to study innovative small molecule candidates for the potential treatment of cardiovascular disease.
According to their agreement, Merck has the option to exclusively license targets and compounds from Xenon for development and commercialization. Xenon then receives research funding and eligibility for exercise fees, research, development and regulatory milestone payments of up to $94.5 million for the first target and up to $89.5 million for each subsequent target used for drug discovery. Xenon will also receive an undisclosed percentage of product sales and retains the right to develop and commercialize certain compounds
Michael Hayden, CSO of Xenon added, “We recognize that Merck is a leading pharmaceutical company with significant presence in and commitment to the cardiovascular space and they are an ideal strategic partner for Xenon. This new alliance, which represents our fifth partnership with a major pharmaceutical company, once again highlights Xenon’s R&D capabilities and validates our drug discovery platform.”
FDA approves Seroquel for adolescents
WILMINGTON, Del. An advisory committee of the Food and Drug Administration has given a positive review to an AstraZeneca drug used to treat schizophrenia and bipolar disorder.
The Anglo-Swedish drug maker announced that the FDA’s Psychopharmacologic Drugs Advisory Committee had given favorable review to its supplemental approval application for Seroquel (quetiapine fumarate). AstraZeneca is seeking approval for the drug as a treatment for schizophrenia in adolescents ages 13 to 17 and bipolar mania in children and adolescents ages 10 to 17.
“We are pleased that the committee found Seroquel to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with biopolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs,” AstraZeneca chief medical officer Howard Hutchinson said in a statement, referring to the company’s supplemental new drug applications.
The same day the advisory committee made its decision about Seroquel, it also voted in favor of Eli Lilly & Co.’s Zyprexa (olanzapine) as a treatment for schizophrenia and bipolar episodes in adolescents, ages 13 to 17.
The committee’s decisions do not constitute approval, but the FDA takes them into consideration when deciding whether to approve a drug.