Zydus Lifesciences gains FDA nod for MS and heart failure treatments

11 Jul 2024 , 12:48 PM

Zydus Lifesciences Ltd made a significant announcement on July 10, 2024, revealing two pivotal FDA approvals.

The first approval grants tentative FDA clearance for diroximel fumarate delayed-release capsules, specifically designed for treating relapsing forms of multiple sclerosis (MS) in adults. Manufactured at their Ahmedabad SEZ facility in India, these capsules have achieved substantial annual sales of $847.4 million in the United States as of May 2024 (IQVIA MAT).

Additionally, Zydus Lifesciences received final FDA approval for sacubitril and valsartan tablets in various doses (24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg), branded as Entresto tablets. This medication is aimed at managing chronic heart failure in adults, effectively reducing mortality risk and hospitalizations. These tablets will be produced at the company’s Moraiya facility in Ahmedabad, India.

As of July 11, 2024, at 12:40 pm Zydus Lifesciences’ stock was trading at ₹1163.30, marking a slight 1.43% decrease from the previous close. Despite this decline, the stock has shown robust growth, surging by 98% over the past year and 66% since the beginning of the current year.

Notably, diroximel fumarate delayed-release capsules have garnered substantial traction in the U.S. market, generating annual sales of $5,483 million by May 2024 (IQVIA MAT).

Since its inception, Zydus Lifesciences has achieved a total of 399 regulatory approvals and has filed over 460 abbreviated new drug applications (ANDAs) since the fiscal year 2003-04, underscoring its proactive approach in the pharmaceutical industry.

Formerly known as Cadila Healthcare Limited, Zydus Lifesciences is headquartered in Ahmedabad, India, and is primarily focused on the manufacture of generic drugs. This Indian multinational pharmaceutical company continues to play a pivotal role in healthcare through its innovative product portfolio and robust market presence.