Emmaus Life Sciences Inc (OTCQX:EMMA) has announced the approval of its application for marketing authorization of its Endari sickle cell treatment from the United Arab Emirates (UAE) Ministry of Health after a five-month review.
During the review period, Endari was available in the UAE on a named patient, or early access, basis only.
Emmaus said it estimates that as many as 600 sickle cell disease patients live or work in the UAE and that there are about 225,000 patients throughout the Middle East-North Africa (MENA) region who could potentially be treated with Endari.
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"We are grateful to have received the Ministry of Health's approval of Endari for the treatment of sickle cell disease patients in the UAE and will move as quickly as possible to reach this population," said Dr Yutaka Niihara, CEO of Emmaus, in a statement.
Adding: "This is the first of several full marketing approvals we hope to obtain in Gulf Cooperation Council states, which represent a very important market, given that there are more than double the number of sickle cell disease patients within these areas than there are in the United States."
George Sekulich, senior vice president of Global Commercialization of Emmaus, commented: "After the extensive review by the Ministry of Health, the approval to market Endari is an important step forward for Emmaus in the MENA region. We look forward to working with our distribution partner to make Endari available to sickle cell disease sufferers in the UAE."
Emmaus is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. The company currently markets the US Food and Drug Administration (FDA) approved Endari to reduce the acute complications of sickle cell disease in adults and children five years and older.
The company is also engaged in the discovery and development of innovative treatments and therapies for certain rare and orphan diseases as well as those affecting larger populations, such as diverticulosis.
Endari, Emmaus' prescription-grade L-glutamine oral powder, was approved by the FDA in July 2017. Sales of Endari began in the US in 2018.
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