INDIA – Major milestone in drug development as Glenmark Pharmaceuticals Limited (Glenmark) has announced the launch of its novel fixed-dose combination (FDC) of sacubitril and valsartan tablets for adults with heart failure in India.
The sacubitril-valsartan combination belongs to the class ARNI (Angiotensin receptor neprilysin inhibitor). These molecules have two therapeutic targets in the treatment of heart failure.
Glenmark said that its generic cardiovascular drug will be marketed under the brand name ‘Sacu V™’ and it must be taken twice every day under doctor’s prescription.
In a press release, global pharmaceutical company stated: “Its approved indication is to reduce the risk of cardiovascular related deaths and hospitalisations for patients with chronic heart failure with reduced ejection fraction.”
The manufacturer explained that its new cardiovascular drug will be available in the form of hard capsules in strengths of 50mg (sacubitril 24mg + valsartan 26mg), 100mg (sacubitril 49mg + valsartan 51mg), and 200mg (sacubitril 97mg + valsartan 103mg).
Glenmark pointed out that the fixed-dose combination of sacubitril and valsartan for adults has been endorsed by the latest heart failure treatment guidelines in Europe and the United States.
Heart failure is the commonest cardiac cause for hospitalization with 1% of the general population being affected annually, which adds up to between 8–10 million patients.
Heart failure patients are unable to tolerate the high level of medications recommended per western guidelines.
Moreover, devices and other advanced therapies commonly used in the developed countries are priced out of range many of the India Based heart failure patients.
Alok Malik, EVP & Business Head ‐ India Formulations, Glenmark Pharmaceuticals Ltd., said with the launch of Sacu V™, the company is offering an advanced and affordable treatment option for patients across India.
“Sacu V™ has been shown to reduce the risk of cardiovascular death or heart failure hospitalisation and to improve symptoms associated with heart failure with reduced ejection fraction,” Malik reaffirmed patients.
Meanwhile, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
The biotechnology company is in advanced talks with Indian drugmaker Eris Lifesciences Ltd to sell its portfolio of dermatology brands for ($41.63 million).
“Post divestiture of the brands, we will further consolidate our position in the core therapeutic areas of cardiometabolic, respiratory, dermatology, and oncology segments,” the Indian pharma giant said.