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Bayer's vericiguat gets NMPA approval in China

DTMT Network

Pharmaceutical powerhouse, Bayer has recently announced that the company has received approval from China’s National Medical Products Administration (NMPA) for its oral nitric oxide stimulator drug vericiguat (Verquvo), jointly being developed with MSD, for reducing the risk of heart failure (HF) hospitalisation or requiring intravenous (IV) diuretics in emergency set-up, in adults with symptomatic chronic HF.

In a statement, Bayer said that the drug works differently from existing heart failure treatments, providing a specific approach to managing chronic heart failure after a recent decompensation event with IV therapy, also known as a worsening heart failure event.

Vericiguat, available in 2.5 mg, 5 mg, and 10 mg dosages, is an oral once-daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signalling pathway.

When NO binds to sGC, the enzyme catalyses the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodelling.

“The approval of Verquvo is an important milestone for heart failure patients across China, providing a new option to help break the cycle of worsening heart failure events; (Such events) can lead to a downward spiral for many patients, resulting in repeated hospitalisation,” Bayer’s Chief Medical Officer Dr Michael Devoy said.

“With each hospital visit, the risk of death increases along with the emotional toll carried by patients and their families,” he added.

Pointing out that the current therapies block the harmful effects of the natural neurohormonal systems that are activated by the myocardial and vascular dysfunction present in heart failure, Bayer said that its vericiguat has a different mode of action and the drug specifically restores the deficient NO-sGC-cGMP pathway, which plays a critical role in the progression of heart failure and aggravating its symptoms.

The drug has been approved in the United States, the European Union, Japan, and many other countries worldwide, while multiple other submissions for marketing authorisations are ongoing worldwide, Bayer said.

 


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