Sanofi receives SEC recommendation to bring new therapies of Pompe, ASMD to India

Sanofi has received a recommendation from the Subject Expert Committee to import and market two new products in India — Nexviazyme (Avalglucosidase alfa powder) and Xenpozyme (Olipudase alfa powder) for Pompe disease and Niemann-Pick disease (ASMD) respectively. “We are hoping to launch these therapies in India by end of 2023 or beginning of next year, subject to completion of all further regulatory steps.”

Both these products have been granted orphan drug status and approval in several countries including the US, Australia, EU, UK and Japan, to name a few.

According to Dr Shalini Menon, Country Medical Lead Sanofi, “Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease. This is a devastating and extremely rare disease that affects both children and adults. The approval of Xenpozyme represents the culmination of bold work done in research and development, and Sanofi’s unwavering commitment to this historically overlooked community.” She said Nexviazyme is for both infantile and late-onset Pompe disease, and showed improvements in respiratory function and walking distance measures.

Sanofi Speciality Care also reaffirmed its commitment to rare diseases in India on the occasion of Rare Disease Day, stating that it will continue with its efforts in empowering the lives of patients with rare diseases by offering transformative healthcare options. Sanofi has been supporting the rare disease day event commemoration in India for 13 years now, ever since the first event was commemorated in 2010 at the Sir Gangaram Hospital, Delhi.

Anil Raina, General Manager, Sanofi Speciality Care (India) said, “Over the past 40 years, Sanofi has launched different therapies for the treatment of many rare diseases, namely Gaucher disease, Fabry disease, Pompe disease, Mucopolysaccharidosis I (MPS I) and Acid Sphingomyelinase deficiency (ASMD). The company also has a global humanitarian program aimed at providing free life-saving treatment to patients in India diagnosed with Lysosomal Storage Disorders (LSDs). Under our India Charitable Access Program (INCAP), we have been supporting patients for Gaucher disease, Pompe disease, Fabry disease and MPS I disease with life-saving Enzyme Replacement Therapy. Many of the children receiving therapy under this programme are now in their teens and adulthood, and are able to lead near-normal lives. More than 1000 patients in over 70 countries are in the company’s global Humanitarian Program today, out of which over 170 patients are from India.