Merck's Winrevair (Sotatercept), a First-in-Class Therapy for Pulmonary Arterial Hypertension, Approved by FDA with Annual Treatment Cost of $242,000
MSD
Pharmaceutical R&D and Manufacturer
Recently,FDA ApprovedMSD's Sotatercept for the treatment of pulmonary arterial hypertension (PAH) has been submitted for marketing approval under the brand name Winrevair. The drug has previously been granted orphan drug and breakthrough therapy designations by the FDA and is the first activin signaling inhibitor therapy targeting PAH.
Winrevair is priced at $14,000 per vial, and for about two-thirds of patients, each vial will last for three weeks.The total cost for the year is approximately 242,000 USD, or about 1.75 million RMB.Chris Schott, a J.P. Morgan stock analyst, predicts that Winrevair will generate $400 million in revenue in 2024; by 2030, sales could approach $5 billion.
Pulmonary Arterial Hypertension (PAH) results from different pathogenic mechanisms leading to structural or functional changes in pulmonary vessels, causing increased pulmonary vascular resistance and elevated pulmonary arterial blood pressure. Symptoms such as hypoxia, respiratory insufficiency, and right heart failure may occur when pulmonary artery pressure rises. Common manifestations include generalized weakness, reduced exercise tolerance, shortness of breath, dizziness, chest pain, chest tightness, palpitations, and syncope.
PAH is a rare progressive disease that is most common in women aged 30 to 60, with a five-year mortality rate of 43%; 500 to 1,000 new cases of PAH are diagnosed each year in the United States, and currently, 40,000 people in the U.S. have been diagnosed with PAH.
Pulmonary hypertension is known as "the cancer of the cardiovascular system."In China, data from 2005 showed that the 2-year survival rate for untreated pulmonary arterial hypertension (PAH) patients was 56.9%, and the 5-year survival rate was 20.8%. Before targeted drugs such as sildenafil, bosentan, and beraprost entered clinical use, there were almost no specific drugs available for PAH. Untreated patients suffered severe impairment of cardiopulmonary function, and even if they survived, they experienced loss of work capacity, poor quality of life, and a poor long-term prognosis. Currently approved drugs for PAH treatment include prostacyclin analogs, phosphodiesterase-5 inhibitors, guanylate cyclase stimulators, prostacyclin receptor agonists, and endothelin receptor antagonists.
Data source: Medlive
According to the report from the U.S. Centers for Disease Control and Prevention,The exact cause of pulmonary arterial hypertension is currently unknown, but some common underlying factors may lead to the condition. Common left heart diseases, such as hypertension and coronary artery disease, if poorly controlled, can also affect the pulmonary vasculature, leading to pulmonary arterial hypertension.。
It is worth noting that there are quite a few new drugs launched in the field of cardiovascular disease systems.For example, Novartis' newcomer in the lipid-lowering field, Inclisiran, has rapidly gained popularity with the claim of "two injections per year effectively lower blood lipids." From the timeline of approval, Inclisiran sodium injection was approved for marketing in the EU in December 2020, in the US in December 2021, and received approval from China's National Medical Products Administration in August 2023 for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia.
Data source: Novartis financial report,整理by中信产业研究中心
Currently, cardiovascular diseases have become a major public health issue faced globally. With the acceleration of China's aging population and urbanization process, unhealthy lifestyles among residents have become increasingly prominent. The impact of cardiovascular disease (CVD) risk factors on residents' health is more significant, and the prevalence and incidence of CVD continue to rise. In 2019, deaths from CVD accounted for 46.74% and 44.26% of total deaths in rural and urban areas, respectively. According to data from the "2021 Report on Cardiovascular Health and Disease in China,"The number of people currently suffering from CVD in China is 330 million, including 245 million with hypertension, 13 million with stroke, and 11.39 million with coronary heart disease., the market demand for related drugs is broad.
Data source: CIC CONSUMIND SYSTEM, CIC Industrial Research Center
As of March 6, 2024, multiple targeted therapies for the treatment of PAH are in the late stages of active development globally, including Gilead's Selonsertib and Biogen's Bardoxolone methyl, both of which are small molecule drugs with diverse targets.
Data Source: WuXi AppTec, Sino Health Industry Research Center
The launch of the new drug has brought new treatment options for patients with cardiovascular diseases and also brought new hope for the prevention and treatment of these conditions. With the continuous advancement of medical technology, it is believed that more effective and safe new drugs will come to the market, bringing good news to patients with cardiovascular diseases.
