LEKLI sh.p.k. announced that the National Agency for Medicines and Medical Devices has validated the Marketing Authorization Application (MAA) for Potassium Iodide (MBROTIR L®). The submission was supported by previously disclosed positive results of two years of work to achieve this vital formula for our current living situation.
“Today marks a significant milestone in our efforts to bring new medicine to the people in Albania, Kosovo, and all around the world who are living the current reality of the difficult situation created by the war in Ukraine combined with the fear and insecurity regarding nuclear power plants all over the world.,” said K. Lekli, Pharm.D., Executive Vice President and CMO at LEKLI. “We are looking forward to working with the National Agency for Medicines and Medical Devices on other important applications.”
About nuclear accidents or nuclear reactor accidents
In the event of accidents in nuclear facilities, particularly nuclear power plants, radioactive iodine may be released and affect the health of the population exposed to the cloud and then to the deposition. When inhaled or ingested, radioiodine tends to concentrate in the thyroid gland, giving rise to high concentrations in this organ. High concentrations of radioiodine in the thyroid gland increases the risk of thyroid cancer development in the exposed people.
When taken in due time at the appropriate dosage, potassium iodide tablets prevent the accumulation of radioactive iodine in the thyroid gland by saturating it with non-radioactive iodine. This protection action is recommended by several international organizations and has been adopted by several countries worldwide.
The ICRP, IAEA, and WHO have taken positions on intervention action level and target population in order to reinforce the prevention measures by targeting the more sensitive groups. These recommendations are based primarily on the results of thyroid cancer research on exposed children.
The recommendations adopted for iodine prophylaxis, in particular those regarding the administration timing, the iodine quantity to be given, and the possible side effects occurring as a result of this measure were made based on the scientific information available to the medical community concerning the effects of stable iodine on the health status of people receiving the treatment. Since then, many teams around the world have continued their research (basic research and clinical research), especially those dealing with the iodine transfer mechanisms through the cells within the thyroid gland, and those regarding the side effects observed after the administration of stable iodine, in response to the information provided by the physicians who noted the adverse health effects observed in people receiving stable iodine.
*) EUROPEAN COMMISSION RADIATION PROTECTION NO 165 Medical effectiveness of iodine prophylaxis in a nuclear reactor emergency and overview of European practices Final Report of Contract TREN/08/NUCL/SI2.520028
