Two Russian children with the rare, progressive brain disorder epileptic encephalopathy have died in the past day, the Russian media outlet Sota reported on Tuesday. Both deaths were the result of the families’ inability to obtain the medication Ganaxolone, which is made in the U.S. and is not registered in Russia. Five more children with the disease could reportedly die in the next three weeks.
The American company Marinus Pharmaceuticals, which manufactures Ganaxolone, previously supplied the medication to Russia as part of its clinical trials. When the trials ended, however, the shipments stopped. Families of children with epileptic encephalopathy are now being forced to give the children reduced doses of the medication in order to preserve the amount they have left for as long as possible.
As part of the drug trials, Marinus, the world’s only supplier of Ganaxolone, included a condition under which parents were to be given permits to import the drug into Russia and obtain documents attesting to its necessity through consultations with doctors. However, while the necessary documents were issued and charity foundations even agreed to pay for the drugs, Marinus has still not received permission from the Russian government to send the medication.
Parents of children with epileptic encephalopathy are planning to launch a hunger strike to demand that the Russian authorities register the drug, according to Sota.
Russian Presidential Children's Rights Commissioner Maria Lvova-Belova has not commented on the situation.