Novo Nordisk develops treatment for rarest bleeding disorder, seeks FDA approval
PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.
The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.
Congenital factor XIII deficiency is considered the rarest bleeding disorder, with only 600 people diagnosed worldwide. Patients with the disease, which results from a lack of the protein clotting factor XIII, have a lifelong susceptibility to bleeding problems, including spontaneous hemorrhages in the brain.
Takeda seeks FDA approval for hypertension treatment
OSAKA, Japan — Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.
Takeda announced that it had submitted an application with the Food and Drug Administration for the fixed-dose drug azilsartan medoxomil and chlorthalidone. Azilsartan medoxomil is an angiotensin II receptor blocker, or ARB, that lowers blood pressure by blocking the angiotensin II hormone.
“Millions of patients with hypertension do not have their condition under control,” said Darryl Sleep, VP clinical science at Takeda Global Research and Development Center. “We believe this compound, the first [in the United States] to combine an ARB with chlorthalidone, could potentially provide an important new treatment option for patients with hypertension and the healthcare providers who manage them.”
Humana’s PBM division enters agreement with AmerisourceBergen
LOUISVILLE, Ky. — Humana Pharmacy Solutions, Humana’s pharmacy benefit management division, on Thursday announced it has selected AmerisourceBergen as Humana’s primary wholesaler for drug purchasing.
“With this agreement, we’ll be able to offer members and employers access to more cost-effective generic versions of clinically proven and popular brand-name drugs,” stated William Fleming, VP Humana Pharmacy Solutions.
The five-year agreement takes effect May 1.