Bayer’s Kogenate FS receives FDA approval
WHIPPANY, N.J. — Bayer HealthCare on Monday announced that the Food and Drug Administration approved the company’s new indication for Bayer’s Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
The approval was based on data from the SPINART (Secondary Prophylaxis in Adults, a Randomized Trial) study: 84 patients ages 15 years to 50 years were randomized to receive either prophylaxis (25-IU/kg three times per week) or on-demand treatment. The results were published in the Journal of Thrombosis and Haemostasis.
"In Bayer’s SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment," said Marilyn Manco-Johnson, M.D., principal investigator of the study and director of the Mountain States Regional Hemophilia and Thrombosis Center at University of Colorado at Denver and Health Sciences Center. "Such clinical information can help healthcare professionals provide appropriate treatment advice to their patients."
Kogenate FS antihemophilic factor (recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly, the company said. It also noted that the drug is not used to treat von Willebrand disease.
Perrigo receives FDA approval for generic Astepro
DUBLIN — Perrigo on Monday announced that it received approval from the Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%), a generic version of Astepro.
The prescription medicine is indicated for people ages 12 years and older and is used to treat nasal symptoms brought on by seasonal allergies or environmental irritants. Annual sales for the drug were approximately $97 million, according to Symphony Health Solutions
"This approval is another example of our investment in new products and expansion of our extended topical product portfolio. We are pleased to be the partner of choice with Impax on this important product opportunity. As always, Perrigo is committed to making quality health care more affordable for our customers," said Joseph C. Papa, Perrigo’s chairman and CEO.
The company’s abbreviated new drug application involves contributions from both Perrigo and Impax Labs; the two companies will share certain costs and benefits of the product.
CHPA files comments to FDA regarding OTC Drug Review
WASHINGTON — The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.
CHPA’s comments underscored its support for the FDA’s re-examination of the system in an effort to complete the OTC Drug Review. CHPA believes this can best be accomplished by utilizing and reforming mechanisms the FDA already has in place.
“The way over-the-counter products are currently regulated has been demonstrably effective for more than 40 years,” said Scott Melville, CHPA president and CEO. “We can improve upon it without undermining a sensible system that has served consumers well.”
In particular, CHPA offered the following suggestions for streamlining the process to promptly resolve the tentative final monographs:
- Accelerating completion of the tentative final monographs through clearer communication on what data/information is needed to complete them;
- Recognizing FDA has ample authority to address emerging safety issues both within and outside of rulemaking, regardless of whether a monograph is final or tentative final;
- Prioritizing and breaking TFMs into smaller parts to finalize what can be finalized without waiting for the whole; and
- Accelerating completion of TFMs through a single point leader outside of Office of New Drugs.