R&D
Japanese approvals marked by
high-need products
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) continues to take various steps to speed
up its reviews of new products with the aim of cutting Japan’s “drug lag”. The agency’s moves to approve products
for serious diseases, particularly cancer, have also been boosted by the allowance over the past few years
of physician-led trials and the formation of a special committee to review drugs in common use elsewhere
but still unavailable in Japan
A
look at the products approved in Sutent (sunitinib) for renal cell carcinoma. worldwide clearance in Japan was for
Japan over the year to November The list also reveals a relatively large Dainippon Sumitomo Pharma’s dopamine
2008 (see Table 1) suggests that number of priority and expedited reviews D2/5HT2 blocker Lonasen (blonanserin)
these initiatives – along with companies’ and orphan drugs, suggesting the PMDA is for schizophrenia.
own efforts to develop their new products making greater use of such designations to
simultaneously in Japan via global trials – speed up the approval of high-need vaccines
are beginning to bear fruit. During the products. In most cases, this is balanced A domestically developed vaccine against
period, close to 40 chemical or biological out by stricter (usually all-patient) H5N1 bird flu was approved in October
entities new to Japan received formal postmarketing surveillance programmes to
2007, but there was little activity
approval from the ministry of health, ensure safety in the real-world setting.
elsewhere in the vaccines area during the
labour and welfare. Actemra, Aroglycem, Champix, Clexane,
review period. Under Japan’s current
The list includes several important Concerta, Erbitux, Nexavar and Sutent
reimbursement policy, prophylactic vaccines
biological therapies, notably Chugai/Roche’s were among the products to receive
are not granted national health insurance
anti-interleukin-6 antibody Actemra priority reviews.
coverage.
(tocilizumab). This product received its first But despite the progress in getting
Two cervical cancer vaccines,
clearance for its main indication of valuable new products onto the Japanese
GlaxoSmithKline’s Cervarix and Banyu’s
rheumatoid arthritis, following on from an market, virtually all of the drugs approved
(Merck & Co) Gardasil, were filed for
earlier approval for the much smaller by Japan in the period studied had already
approval in Japan in the last quarter of
orphan indication of Castleman’s disease. been launched elsewhere, often several
2007 but have yet to be approved.
In the oncology area, which is seeing years previously.
rapid growth in Japan, important approvals The number of global first approvals in
Ian Haydock is Scrip’s Asia
editor.
included ImClone Systems/Merck KGaA/ Japan remained small, perhaps reflecting
Bristol-Myers Squibb’s Erbitux (cetuximab) the Japanese industry’s ever-increasing
for colorectal cancer, and Bayer Schering emphasis on the US as its priority market.
Pharma’s Nexavar (sorafenib) and Pfizer’s Besides Actemra, the only other first
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