LONDON—AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK-based pharmaceutical company, has announced that its rare disease therapy Strensiq (asfotase alfa) has been granted market access by the Guangdong Medical Products Administration (MPA) bureau. This approval is a significant step under the “Hong Kong-Macau Drug and Device Access” policy, which facilitates the availability of drugs to patients across the Greater Bay Area, including Hong Kong, Macau, and Guangzhou cities.
Strensiq serves as a vital long-term enzyme replacement therapy for patients afflicted with hypophosphatasia (HPP), a rare inherited metabolic disorder characterized by a deficiency in alkaline phosphatase (ALP). This deficiency hampers bone mineralization and osteopontin production, causing skeletal issues, bone fragility, and a range of severe complications such as fractures, bone pain, impaired mobility and respiration, epilepsy, and a significantly diminished quality of life.
First approved in Japan in July 2015, asfotase alfa has been recognized as the pioneering and sole enzyme replacement therapy for HPP. Since then, it has garnered marketing approvals in the European Union and the United States, establishing its global footprint in addressing this ultra-rare condition.
The recent approval in Guangdong not only broadens the therapeutic options for HPP patients in the region but also exemplifies the ongoing commitment of AstraZeneca to bring innovative treatments to those suffering from rare and complex diseases worldwide.- Flcube.com