Japan's Ministry of Health, Labor and Welfare (MHLW) said 6 drugs were named under its first announcement on the new "sakigake" fast-track review system and include Merck's ($MRK) Keytruda for the treatment of advanced unresectable gastric cancer.
The ministry said Oct. 27 that in addition to Keytruda (pembrolizumab--gene recombination), other accepted candidates included ASP2215 from Astellas Pharma for first relapse or treatment-resistant of FLT3 gene mutation-positive acute myeloid leukemia; BCX7353 from Integrated Development Associates; S-033188 for influenza virus infection from Shinogi; NS--065/NCNP-01 for Duchenne muscular dystrophy from Nippon Shinyaku; and Sirolimus for angiofibroma from Nobel Pharma.
Roger Perlmutter, president of Merck Research Laboratories, mentioned the designation on the Oct. 27 third quarter earnings call.
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| Japan Health Minister Yasuhisa Shiozaki |
The system is now a pilot program that stands outside the Pharmaceuticals and Medical Devices Agency's (PMDA) full-review process. Any products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world, PMDA said in April.
Designation means prior reviews before the launch of Phase III clinical studies. The time between Phase III document submissions and clinical trial consultations will be reduced from two months to one month, and the review period from 12 months to 6 months.
The PMDA has also started consultation services to academic institutions on protocols for their Phase IIb or later confirmatory studies, aiming at products with great unmet medical needs.
In September, MHLW sought more funds next budget year to pursue innovative drug and medical device development as it also struggles with growing healthcare costs in part brought on by a weaker yen that has made imports more expensive.
- here's the MHLW press briefing and release (Japanese)