Merck Announces FDA Acceptance of Biologics License Application for Immunotherapy Tablet
News Mar 28, 2013
In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.
The BLA for Merck’s grass pollen AIT is supported by Phase III trials that evaluated the safety and efficacy of the investigational product, including a long-term, multi-season trial.
“We are pleased to have achieved this important milestone in the development of our investigational grass pollen AIT, which, if approved, would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients,” said Jeffrey A. Chodakewitz, M.D., senior vice president, Global Scientific Strategy, franchise head, Infectious Diseases and interim franchise head, Respiratory & Immunology, Merck Research Laboratories.
Merck's grass pollen (Phleum pratense) AIT is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against targeted allergens. Merck has partnered with ALK-Abello to develop its grass pollen (Phleum pratense) AIT in North America.
A team led by Johns Hopkins Medicine researchers says it has identified two protein biomarkers in urine that may one day be used to better diagnose acute interstitial nephritis, an underdiagnosed but treatable kidney disorder that impairs renal function in the short term and can lead to chronic kidney disease, permanent damage or renal failure if left unchecked.READ MORE