MINISTRY OF HEALTH APPROVES KOSELUGO WITH "ORPHAN MEDICINE" STATUS
PUTRAJAYA (April 6, 2023): The Ministry of Health (MOH) has agreed to give ‘orphan medicine’ status to Koselugo Hard Capsules 10 milligrammes (mg) and 25 mg, said Health director-general Tan Sri Dr Noor Hisham Abdullah.
In a statement today, Dr Noor Hisham said the decision to approve the product was made at the 383rd Drug Control Authority (PBKD) meeting convened today.
Koselugo is a prescription drug used in the treatment of children, aged three and above, with a rare disorder called neurofibromatosis type 1 (NF1).
He said the drug, produced by Patheon Pharmaceuticals Inc., in the US, was given the orphan medicine status after it was processed as a ‘priority review’.
According to him, the evaluation period for the ‘priority review’ registration is 120 working days compared to 245 working days for the normal registration route.
“Koselugo is the first product approved by PBKD for neurofibromatosis type 1 with inoperable plexiform neurofibromas,” he said.
NF1 is listed as a rare disorder in the Malaysian Orphan Medicines Guideline.
Dr Noor Hisham added that MOH through the National Pharmaceutical Regulatory Agency (NPRA) will continue to monitor and evaluate the latest data from time to time regarding information on the quality, safety and effectiveness of the Koselugo product.
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