The Ministry of Health and Community Protection announced that it has completed the registration of the drug "Locastorna" for the treatment of blindness caused by the retinal retinal atrophy, while the company responsible for marketing of medicine outside the United States «Novartis», that the drug will be available within the state before the end of this year, Given once in a lifetime, worth two million and 26 thousand and 390 dirhams.
The company explained to the «Emirates Today» that the drug will be available within the state before the end of this year, the first gene drug to cure blindness resulting from the genetic retinal atrophy in the world.
"The registration of the innovative gene drug Lucastrana for the treatment of blindness caused by retinal atrophy is due to a mutation in two copies of the RPE65 gene with the presence of live retinal cells," said Dr. Mohammad Salim Al Ulama, deputy head of the Higher Committee for Drug Registration and Pricing. The ministry has utilized an innovative mechanism for its operational accelerators, which have been allocated to evaluate and certify the world's leading and first-class drugs, in the fast track of Accelerate Process / Fast Track.
He pointed out that the adoption of this innovative drug comes in implementation of the ministerial decision on the registration of innovative and rare medicines, No. 28 of 2018, issued by the Minister of Health and Community Protection, Abdul Rahman bin Mohammed Al Owais, and within the framework of the continued support of the UAE for the International Strategy «Vision 2020 - Vision ", launched by the World Health Organization to combat blindness in the world.
The UAE has adopted this treatment as it opens up future prospects for genetic treatments, which will help treat many diseases. The state's adoption of this treatment is the third global approval in the health authorities, in line with the Ministry's strategy to build quality, health, "We are witnessing an important turning point as experts expect to expand the scope of gene therapy to include a range of other incurable diseases," he said. The international pharmaceutical companies are keen to provide the UAE with innovative medicine files, in parallel with its offer to international bodies such as the FDA and the European Medicines Authority (EMEA) to obtain global accreditation, including review of clinical studies, bioequivalence studies and stability studies. .
He pointed to the leadership of the UAE in protecting the intellectual property of innovative and rare medicines and enhancing innovation in medicine as a key factor in finding effective solutions to treat complex and intractable diseases within the framework of the Ministry's strategy aimed at providing a legislative framework and vital governance. , Through the development of health legislation in the country in line with the objectives of Vision 2021.
The flexible regulatory environment in the UAE has established its position in the global drug market to become a leading attraction for international pharmaceutical companies, giving them a differential advantage over their peers. These companies have made the UAE a center for marketing their innovative products, providing solutions to patients in the UAE and the region, And promotes health tourism.
He said the ministry's strategy of sustainable solutions aims to provide one-time treatments for intractable diseases that provide health care providers with long-term expenses, compared with traditional treatments that the patient may need for years to come, which drains spending on treatment, Health in the world. "We have received good news that Luxturna, the first gene therapy in the UAE, has been successfully registered with the Ministry's rapid registration track, and we look forward to strengthening our presence in the region," said Dr. Mohammad Ezzeldin, Regional Director, Novartis Gulf. Patients on this global treatment that is likely to change their lives ».
"For those born with a mutation in two copies of the RPE65 gene, nearly 60% of patients have severe forms of the disease, with severe visual impairment occurring shortly after birth, RPE65 gene mutations occur in about one in every 200 thousand Which makes the disease very rare, and most patients will inevitably end up losing sight, putting a heavy burden on them, their families and health care systems, hence the importance of this innovative drug, Lucastorna, which works to regain sight and improve vision. "
- The drug will be available within the state before the end of this year.
- Scientists: The flexible legislative environment in the UAE has established its global standing.