Pfizer's Sildenafil Citrate for Pulmonary Hypertension Nears Approval in China Following Priority Review Designation

By winter

On February 3, the Center for Drug Evaluation (CDE) officially released a batch of drugs proposed for priority review and approval, including Pfizer’s “Sildenafil Citrate Tablets,” which was included on the list due to its designation as a treatment for rare diseases; it had previously been included in the list of overseas new drugs urgently needed for clinical use.

The Insight database shows that the new indication marketing application for this drug was accepted by the CDE on September 26, 2019 (acceptance number: JXHS1900118). The technical review has now been completed, and its status has changed to "under approval," with market approval expected imminently.

Sildenafil, a PDE5 inhibitor, was first approved in 1998 for the treatment of erectile dysfunction (ED) in men; in November 2009, it received FDA approval for the treatment of pulmonary arterial hypertension.

Pulmonary Hypertension (PH) is a pulmonary vascular disease characterized by a sustained increase in pulmonary vascular resistance, which can ultimately lead to cardiac and respiratory failure. Currently, there is no cure for pulmonary hypertension, and patients require lifelong pharmacological treatment.

Latest epidemiological data estimate that the prevalence of pulmonary hypertension (PH) is approximately 1% of the global population. The prevalence of PH reaches as high as 10% among individuals aged 65 years and older, and it also frequently affects younger populations. It has become a major category of diseases posing a serious threat to public health.

The drug was first approved for import in China in 2002, with approval granted solely for the indication of erectile dysfunction (ED). The inclusion of the pulmonary hypertension (PH) indication in the priority review program means that patients with pulmonary hypertension in China will soon have access to a high-quality, highly effective, and affordable medication.

Note: The original text has been abridged.