Leader in sickle cell disease treatment, Emmaus Life Sciences Inc (OTC:EMMA) announced receiving marketing authorization from the Oman Ministry of Health for commercial distribution as well as the sale of Endari for treating the disease in patients five years of age and older. There are about 3,000 patients having the disorder in the country and about 6% of Omanis are carriers of the gene for sickle cell anemia.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus expressed delight on receiving the authorization in Oman, where sickle cell disease is a health issue impacting thousands of families. Niihara added that the approval is a significant milestone for improving the lives of people globally.
George Sekulich, Senior Vice President of Global Commercialization of Emmaus Life Sciences, Inc said that the approval for Endari is a vital step in the GCC region, where the firm has been working closely with physicians, authorities, and patients for ensuring access to treatment for sickle cell disease. Sekulich added that the firm is looking forward to launching Endari commercially in Oman and expanding availability to other countries.
The treatment is approved for marketing in Israel, the US, Bahrain, Qatar, UAE, and Kuwait. Emmaus is also looking for more regulatory approvals for Endari in other countries.
Emmaus Life Sciences Inc announced receiving Medicine Registration Certificate from the Bahrain National Health Regulatory Authority. This will enable the company to sale and commercial distribution of Endari in the Kingdom of Bahrain. Endari is approved in UAE, U.S, Kuwait, Qatar, and Bahrain for reducing acute complications of sickle cell disease both in pediatric and adults.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus said that the company is grateful to Bahrain officials for viewing Endari as vital for sickle cell patients in the country. Niihara added that it will further the mission to provide access to Endari in North Africa and the Middle East region besides India, for their underserved and large sickle cell disease patient populations.
George Sekulich, Senior Vice President of Global Commercialization of Emmaus said that the approval from NHRA is a validation of the efficacy and safety of Endari. Sekulich added that the firm is looking forward to working with Gulf Pharmacies and partners for making Endari available to sickle cell disease patients in the country. Sekulich added that the company is expecting final action on the application in the Kingdom of Saudi Arabia, where Endari is available on an early access basis only.
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company engaged in the development, marketing, and sale of innovative treatments and therapies.