Following the approval in Europe on Feb. 22, the Food and Drug Administration gives Bayer's Kovaltry therapy for hemophilia A the green light in the U.S. Kovaltry is designed to lessen the bleeding in hemophilia A patients and can be used twice to thrice a week.
The FDA's approval was based on the results of Kovaltry's clinical trials wherein the therapy successfully demonstrated that it can control bleeding and reduce the number of episodes through repetitive prophylaxis.
The patients involved in the LEOPOLD clinical trials were both adults and children diagnosed with hemophilia A. In the trials, Kovaltry was given two to three times a week.
In hemophilia A patients, the gene that controls blood clotting is faulty. This faulty gene makes them bleed spontaneously or severely in surgery or injury cases especially in the muscles, internal organs and joints. Also known as "factor VII deficiency" or "classic hemophilia," the bleeding disorder is inherited and is believed to affect approximately 16,000 people in the U.S. alone.
To date, the condition has no known cure. Hemophilia A patients need to be injected with blood clotting proteins regularly. This type of maintenance can lead to a $300,000 yearly cost for one patient alone. So far, Kovaltry has no specific price tag yet, according to a spokeswoman for Bayer, but members of the pharmaceutical company said they are proud of the newly developed treatment.
"We are proud that, based on our comprehensive development program, physicians can now consider twice weekly prophylactic treatment with Kovaltry among the treatment options," said Dr. Joerg Moeller, Executive Committee member of the drugmaker's Pharmaceutical Division and Head of Development.
Moeller added that the drug company has been developing hemophilia A treatments for over 20 years. Kogenate, Bayer's already established hemophilia A therapy raked in nearly $1.30 billion in global sales last year. Kogenate is sold in over 70 countries around the world.
"It is vitally important that people are able to choose from a range of treatments, and we applaud Bayer for bringing forth new product options to help people manage their disease," said Val Bias, the CEO of the National Hemophilia Foundation in the U.S. "Hemophilia care has changed significantly in recent years, but we have a long way to go to help those living with hemophilia."
Photo : Sebastian Rittau | Flickr
