Japan's Ministry of Health, Labour and Welfare (MHLW) has granted sakigake fast-track designation to six drugs as the first batch of products approved under its new approval pathway.
IHS Life Sciences perspective | |
Implications | The approvals include five Japanese drug makers, including Nobelpharma (Japan)'s angiofibroma associated with nodular sclerosis treatment Sirolimus (NPC-12G), as well as Merck & Co (US)'s Keytruda (pembrolizumab) for gastric cancer. |
Outlook | The six drug makers are expected to benefit from accelerated time-to-market, and also serve as a test example for the new approval pathway, which reflects the MHLW's intention to intensify its drive to promote innovative therapies. |
Japan's Ministry of Health, Labour and Welfare (MHLW) has announced six drugs as the first batch of products designated under its sakigake fast-track review system, which is being rolled out this fiscal year on a trial basis:
Japan's MHLW designates first batch of products under sakigake fast-track review system | ||
Drug | Company | Indication |
Sirolimus (NPC-12G) | Nobelpharma (Japan) | Angiofibroma associated with nodular sclerosis |
NS-065/NCNP-01 | Nippon Shinyaku (Japan) | Duchenne muscular dystrophy |
S-033188 | Shionogi (Japan) | Influenza A or B virus infection |
BCX7353 | Integrated Development Associates (Japan) | Angioedema attacks in patients with hereditary angioedema |
ASP2215 | Astellas (Japan) | First-relapsed or treatment-resistant FLT3 mutation-positive acute myeloid leukaemia |
Pembrolizumab (Keytruda) | MSD (US) | Unresectable, advanced or recurrent gastric cancer |
Source: Pharma Japan | ||
The sakigake fast-track system is part of Japan's overall strategy of accelerating the drug-development and regulatory approval process through all stages, including research and development and clinical trials, pre- and post-marketing safety, marketing approval, National Health Insurance (NHI) reimbursement price listing, and international deployment. The sakigake designation confers a range of advantages to both domestic and multinational drug makers, mainly targeting innovative treatments, medical devices, and regenerative treatments which have the ability to cure rare and serious diseases.
Eligibility for sakigake designation depends on four specific criteria: a novel mechanism of action; desirability of early commercialisation; demonstration of prominent effectiveness; and the treatment having been developed and received targeting approval in Japan prior to other countries, including global simultaneous submissions. Regulators in Japan hope the sakigake approval pathway will cut pharmaceutical review times by half (see Japan: 15 October 2015: Japan's regulators aim to halve pharmaceutical approval time with fast-track sakigake pathway).
Outlook and implications
The first six drug makers to benefit from the sakigake fast-track designation are expected to benefit from accelerated time-to-market, and also serve as a test example for the new approval pathway. In particular, the designation is expected to shrink the consultation time on clinical trials from an average of two months to one month, and the post-Phase III review time from 12 months to 6. However, for the first year of operation of the sakigake system, the MHLW is aiming to avoid affecting the Pharmaceuticals and Medical Devices Agency (PMDA)'s existing review structure as far as possible.
The fast-track designation is expected to further boost innovation in Japan, which over recent years has introduced a raft of policies – including raising its ceiling on innovation premiums and favourable laws to encourage the regenerative-therapies sector – to effectively reduce its longstanding 'drug lag'. In particular, awarding fast-track designation to Merck & Co (US)'s PD-1 gateway inhibitor Keytruda (pembrolizumab) is another step towards facilitating market access for the innovative therapy, though the NHI reimbursement price remains to be seen. Similarly, in September 2014 Japan became the first country to reimburse PD-1 inhibitor Opdivo (nivolumab), and the latest raft of approvals indicates that the MHLW intends to intensify its drive to promote innovative therapies (see Japan: 26 August 2015: Japan's Comprehensive Strategy for pharmaceutical sector calls for innovation and M&A).