Orphan drugs introduced in Korea are 'increasing'

PMS of Crysvita is 11 years, and PMS of Vyndamax is 10 years

As the orphan drug market has recently emerged as Blue Ocean, the introduction of Orphan Drugs by global pharmaceutical companies is increasing in Korea.

 

In particular, as the MFDS has given a PMS of up to 11 years to Orphan Drugs through amendment of regulations, the market monopoly is expected to be prolonged.

 

According to the MFDS on the 12th, two of the recently approved Orphan Drugs have been granted PMS for more than 10 years.

 

PMS, which means re-examination of new drugs, is subject to investigation conditions after being marketed during the period, but it also has a data protection function, blocking entry of generic drugs, and thus gaining market monopoly.

 

Since 2017, the MFDS has been granting PMS for 10 years, up to 11 years, in recognition of its contribution to the development of Orphan Drugs with fewer patients and no alternative drugs, and 11 years are granted for pediatric clinical trials.

 

Until last year, only two drugs were given PMS for 10 years.

 

The two drugs are 'NexoBrid', which removes the eschar without harming viable tissue by BL&H in 2018 and 'Raxone', a treatment for visual impairment caused by Leber Hereditary Optic Neuropathy by DKSH Korea in 2019.

 

In August, Pfizer's PMS of 'Vyndamax (Amyloid Cardiomyopathy (ATTR-CM) treatment)' was given 10 years, and in September Kyowa Kirin's PMS of ‘Crysvita' was given 11 years.

 

Crysvita is a treatment for hereditary hypophosphatemia (XLH), and PMS has been recognized for 10 to plus 1 year, up to 11 years because of the results of pediatric clinical trials.

 

Accordingly, Crysvita is exclusive in the market, with data protected until September 16, 2031.

 

An official from the MFDS said, "PMS is granted for 10 years, up to 11 years for orphan drugs that do not have alternative drugs.

 

" In addition, he explained, "In order to support the development of orphan drugs with a small number of patients, we are operating the existing PMS grant period (6 years for new drugs and 4 years for improved drugs)."