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
24 September, 2018 11:50 IST
Sun Pharma's arm receives USFDA approval for new label for Odomzo
Source: IRIS | 20 Sep, 2017, 10.50AM
Comments  |  Post Comment

Sun Pharmaceutical Industries today announced that one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo(sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

Odomzo was approved by the FDA in July 2015, based on 12-month follow-up results from the pivotal Phase II Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT) clinical trial, a multicenter, double-blind study involving 194 patients with laBCC and 36 patients with metastatic basal cell carcinoma (mBCC). The new label now incorporates long-term data from the 30-month analysis of BOLT trial, in which Odomzo continued to show sustained durable tumor response of 26 months with no new safety concerns.

''We are pleased to incorporate the additional data to the Odomzo label, as they show that Odomzo is the only clinically proven hedgehog inhibitor which, by independent central review, maintains lasting tumor response for 26 months,'' said Kirti Ganorkar, Global Head, Business Development at Sun Pharma. (Q,N,C,F)* ''The rigor of the BOLT study design and results analyses should reassure patients and physicians that Odomzo can treat this devastating and sometimes disfiguring disease over the long term.''

Shares of the company declined Rs 8.85, or 1.71%, to trade at Rs 507.75. The total volume of shares traded was 170,766 at the BSE (10.37 a.m., Wednesday).

Comments Post comment 
 Post Comment
Name Email
Comment
Security Code type    into this box
Company Update
Tatas to acquire Usha Martin's steel business for up to Rs 47 bn - 24-Sep-2018 10:05
Sequent Scientific to acquire Solara Active Pharma Sciences' EU-GMP API facility - 24-Sep-2018 09:48
Biocon announces successful USFDA inspection of its Bangalore facility - 24-Sep-2018 09:45
Godrej Properties adds a new residential project in Noida, NCR - 24-Sep-2018 09:42
ITD Cementation India wins orders worth Rs 8.45 bn - 21-Sep-2018 15:44
Emami Paper Mills to invest around Rs 20 bn in Gujarat - 21-Sep-2018 15:03
Tijaria Polypipes receives single order worth Rs 353 mn - 21-Sep-2018 13:13
Infosys to open technology and innovation hub in Arizona - 21-Sep-2018 13:08
Pennar Group bags orders worth Rs 1.81 bn - 21-Sep-2018 13:05
TCS recognized as leader in finance and accounting digital augmentation suite - 21-Sep-2018 12:30
Sun Pharma announces Australian TGA approval of ILUMYA - 21-Sep-2018 12:06
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