Glenmark Pharmaceuticals, a global pharmaceutical company has announced that company has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris (rye - al’ - tris), an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.
Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name. “Our first NDA submission with Ryaltris is the culmination of years of diligent effort by our employees and clinicians,” said Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. “This is an important milestone for Glenmark, and another step in our rapid transition into becoming an innovation-led and discovery-driven life sciences company.” Glenmark expects the FDA will determine whether the NDA is complete for filing within 60 days. If the NDA is accepted, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned at that time. Glenmark has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Phase 3 results of Ryaltris have been previously presented at key medical meetings, most recently at the Joint Congress of the American Academy of Allergy, Asthma and Immunology and the World Allergy Organization held in March 2018.
About Seasonal Allergic Rhinitis
According to the most recent CDC data, over 17 million adults in the United Sates are affected by seasonal allergic rhinitis, also called hay fever, every year.1 It is the primary diagnosis in over 11 million doctor’s visits annually and is estimated to affect more than seven percent of adults aged 18 and over in the United States.1,2
About Glenmark’s Respiratory Pipeline
Glenmark’s respiratory pipeline is specifically aimed at addressing the global public health burden of allergic rhinitis, asthma and chronic obstructive pulmonary disease (COPD), and includes investigational treatments across the disease spectrum. This includes Ryaltris (GSP 301 Nasal Spray), a combination antihistamine plus steroid nasal spray for the treatment of seasonal allergic rhinitis. It also includes GBR 310 (omalizumab), a proposed biosimilar candidate intended for the treatment of allergic asthma and chronic idiopathic urticaria; and GRC 39815, which is being investigated pre-clinically for the treatment of COPD and other respiratory diseases.
Glenmark Pharmaceuticals Inc. gets approval of USFDA for Colesevelam Hydrochloride Tablets
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride Tablets, 625 mg, the generic version of Welchol Tablets, 625 mg, of Daiichi Sankyo Inc.
The company has already commenced supplies of the product to the US market. According to IQVIATM sales data for the 12 month period ending March 2018, the Welchol Tablets, 625 mg market achieved annual sales of approximately $519.9 million*. Glenmark’s current portfolio consists of 135 products authorized for distribution in the U.S. marketplace and 62 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. 1All brand names and trademarks are the property of their respective owners. 2Market includes brand and all available therapeutic equivalents *IQVIATM National Sales Perspectives: Retail & Non-Retail, March 2018
About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of oncology, dermatology and respiratory. The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark along with its subsidiary has 17 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.