Drug for Duchenne muscular dystrophy to become available in Georgia early next week
Givinostat for Duchenne muscular dystrophy to arrive in Georgia
According to Georgian Health Minister Mikheil Sarjveladze, the drug givinostat, used to treat Duchenne muscular dystrophy, will arrive in Georgia early next week. He said all the necessary preparations have already been completed so that doctors can begin using the drug in the country as soon as possible.
“Today we have another piece of good news: we have received confirmation that the drug givinostat has been sent to Georgia by air mail. This means the medicine will arrive in Tbilisi by the beginning of next week.
We have carried out extensive preparations together with Italfarmaco. In particular, we have recorded patient data with the utmost accuracy, created a dedicated registry, approved the relevant regulations, and had foreign specialists train doctors. Everything is now ready to start using the drug in practice as soon as possible,” Sarjveladze said.
He said parents can call the ministry’s hotline for information and advice on how the medicine will be used.
Sarjveladze also spoke about another drug for Duchenne muscular dystrophy. The ministry has been negotiating with its manufacturer in parallel with the talks on givinostat. The minister said he hoped the two sides would sign an agreement within days.
The drug in question is Elevidys, which doctors use to treat Duchenne muscular dystrophy.
“In this case, I would like to share some good news with the public: we have completed negotiations on all the key commercial issues. We have already prepared and issued all the necessary legal acts on our side and confirmed that we are fully ready to sign the agreement.
We are now waiting for the company’s response and are confident that we will sign the procurement agreement for this medicine within days.
It is worth noting that the negotiations took longer than expected. This was mainly because of our firm position that we must clearly define and insure the responsibilities and obligations of the relevant parties regarding the quality of the medicine,” Sarjveladze explained.
The minister also thanked the parents of children with Duchenne muscular dystrophy for their active involvement in the process.
Background
On 31 July, Sarjveladze announced that the government would purchase givinostat for patients with Duchenne muscular dystrophy.
Parents of children with the condition first met Prime Minister Irakli Kobakhidze on 3 June. After a second meeting on 4 June, Kobakhidze announced the creation of a working group to address the supply of the medicines the children need.
After the meeting, the parents said the authorities had agreed to provide the medicines. They expected two specific drugs to arrive in Georgia in about two months.
On 8 July, after meeting Health Minister Mikheil Sarjveladze, the parents said negotiations on making one of the drugs available in Georgia had reached the final stage. They added that they would announce details of the talks on the second drug the following week.
Duchenne muscular dystrophy is a rare genetic disorder that causes progressive muscle weakness and muscle damage. It mainly affects boys, with symptoms usually appearing in early childhood. As the disease progresses, it can also affect the respiratory and heart muscles. There is currently no cure, but treatment can slow the progression of the disease.
Givinostat for Duchenne muscular dystrophy to arrive in Georgia
