Live news , top stories, corporate news, company news, sector news, economy news, results analysis news, ceo interviews, fund manager interview, advisor interview, market news, bazaar talk, hot stocks news, ipo news, commodities news, mutual fund news, insurance news, news wire
21 October, 2018 20:32 IST
Glenmark Pharma gets USFDA acceptance for new drug Ryaltris
Source: IRIS | 08 Aug, 2018, 09.47AM
Comments  |  Post Comment

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the company's New Drug Application 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.

''We are pleased that Glenmark's rigorous study of Ryaltris led to today's filing acceptance by the FDA,'' said Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. (Q,N,C,F)* ''We look forward to offering a potential new treatment option for people suffering from seasonal allergic rhinitis.''

The filing for Ryaltris includes efficacy and safety results from two pivotal, randomized, multicenter, double-blind, placebocontrolled trials in adults and adolescents 12 years of age and older with SAR. The similarly designed trials lasted two weeks and enrolled 2,352 patients. Assessment of efficacy was based on patient-reported reflective total nasal symptom score (rTNSS), along with other patient-reported measures of nasal and ocular symptoms. Across the two studies, treatment with Ryaltris resulted in statistically significant improvements in rTNSS compared to placebo.

Additionally, the filing includes data from a long-term safety study in 601 adults and adolescents 12 years of age and older with perennial allergic rhinitis (PAR). This trial was a three-arm, double-blind, randomized, parallel group, placebo-controlled safety study that randomized patients to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. The study also evaluated efficacy as a secondary endpoint, assessed as change from baseline in average morning patient-reported rTNSS. Ryaltris demonstrated a statistically significant and clinically meaningful improvement compared to placebo (p<0.0001) over 52 weeks of treatment.

The incidence of adverse reactions in four placebo-controlled clinical studies was 13.9% in the Ryaltris treatment groups versus 9.5% of patients in the placebo groups. The most frequently reported adverse reactions with Ryaltris greater than placebo was loss of taste sensitivity (3.0% vs. 0.3%, respectively), nosebleed (1.0% vs. 0.6%) and nasal discomfort (1.0% vs. 0.8%).

Shares of the company declined Rs 1.2, or 0.2%, to trade at Rs 588.15. The total volume of shares traded was 1,968 at the BSE (9.38 a.m., Wednesday).

Comments Post comment 
 Post Comment
Name Email
Comment
Security Code type    into this box
Sector
Lupin's Pithampur unit-3 inspected by USFDA - 19-Oct-2018 16:01
Surya Roshni bags order worth Rs 503.4 mn - 19-Oct-2018 11:22
Glenmark Pharma to present data on investigational treatment for Atopic Dermatitis - 19-Oct-2018 09:55
Roadmap to promote aircraft manufacturing on anvil: Suresh Prabhu - 19-Oct-2018 09:36
Zydus Cadila receives tentative approval for Colchicine tablets - 18-Oct-2018 16:21
Ramco Systems partners with Airbus Helicopters SAS - 18-Oct-2018 10:26
ABB secures order worth Rs 1.15 bn from Indian Railways - 18-Oct-2018 10:20
Zydus Cadila gets nod for Clobetasol propionate cream - 17-Oct-2018 15:19
Aurionpro Solutions to acquire majority stake in Singapore based SC Soft - 17-Oct-2018 13:26
L&T Technology Services completes acquisition of Graphene Semiconductor Services - 17-Oct-2018 13:22
Adani Group partners with Total to provide multi-energy offering - 17-Oct-2018 13:16
more...
Home  |   Shares  |   F&O  |   Mutual Funds  |   Loans  |   Insurance  |   News Centre
Wealth Tracker  |   Newsletters  |   Tax Corner  |   NRI Centre  |   Advertise
© All rights reserved. IRIS Business Services Limited
A Disclaimer