Cipla receives USFDA nod to market Lanreotide injection in US market
- ByStartupStory | December 20, 2021
Drug major Cipla on Sunday said it has received approval from the US health regulator to market the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, in the American market.
The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.
Lanreotide injection is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs), it added. It is supplied in 60 mg/0.2 ml, 90 mg/0.3 ml, and 120 mg/0.5 ml single-dose pre-filled syringes.
“We are pleased to receive the final approval for Lanreotide injection from the USFDA. Enabling access to high-quality treatments is core to our purpose of ‘Caring for Life’. This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs,” said Umang Vohra, MD and Global CEO, Cipla.
The active ingredient’s route of administration and strengths are the same as Somatuline Depot, from Ipsen Biopharmaceuticals Inc. According to Iqvia, Somatuline Depot had sales of approximately $867 million for the 12-month period ending October 2021. Foreign research firm Nomura has kept a ‘buy’ call on the stock with a target at Rs 1,051 per share.
The company has got the FDA nod for Lanreotide Depot Injection under 505b(2) pathway. Nomura expect Lanreotide Depot Injection to be launched soon. “The approval is a positive surprise and is not factored into our earnings estimate,” it added.
The share touched a 52-week high of Rs 1,005 and a 52-week low of Rs 738.25 on September 29, 2021 and March 19, 2021, respectively. It was trading 12.4 percent below its 52-week high and 19.25 percent above its 52-week low on Monday morning.
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