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  • Global orphan drug Lamzede receives GIFT designation
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Dec 15, 2023 05:51am
in Korea¡¦a global orphan drug sold exclusively by Kwang Dong Pharmaceutical
Company signed an exclusive domestic sales and distribution contract with an Italian pharmaceutical company in July
MFDS has designated 23 GIFT drugs since the system launch
'Lamzede Inj (velmanase)¡¯ received the Global Innovative Products on Fast Track (GIFT) designation and will receive an expedited review in Korea. Lamzede is an orphan drug for which Kwang Dong Pharmaceutical signed an exclusive sales and distribution agreement with Italy's Chiesi Farmaceutical in July this year.

As the GIFT program seeks to shorten the review period by at least 25%, the drug could be granted within 90 working days if Kwang Dong Pharmaceutical thoroughly submits the required supplementary materials.

The Ministry of Food and Drug Safety recently announced that it had designated Lamzede, an enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to
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