Fri, Mar 07, 2014 - Page 3 News List

Food and drug body says developments last year ‘excellent’

POSITIVE RESULTS:The agency said Taiwan had seen several ‘firsts’ in research into vaccines, including for cancer and the H7N9 avian influenza

By Alison Hsiao  /  Staff reporter

The country’s clinical trials for drugs, and research and development for new drugs achieved outstanding results last year, the Food and Drug Administration (FDA) said.

According to the agency, the government’s long-term efforts to grow the biotech and pharmaceutical industries are seeing positive results.

The clinical trials conducted in Taiwan are excellent not only in quantity, but also in quality “garnering several ‘firsts’ in the field,” the agency said.

Afatinib, a targeted therapy for non-small cell lung cancer, had clinical trials that were executed in various centers around the world, including at Taiwan’s six medical centers, with a total of 566 patients participating in the trials, the agency said.

Taiwan was the first country to have the drug approved and made available on the market, it added.

The vaccine manufacturers and research institutions in the country have also been working on developing an H7N9 vaccine in response to the ongoing outbreak of the avian influenza in China, the agency said.

The agency said it has initiated a “rolling review” to speed up approval of new drugs and because of the new program, the H7N9 vaccine is expected to begin clinical trials this year.

Taiwan is also taking big steps toward developing a vaccine for meningococcal meningitis, which is caused by the bacteria Neisseria meningitidis, the agency said.

Six of the 12 identified segrogroups of N. meningitidis — A, B, C, W135, X and Y — can cause epidemics, and the nation has been experiencing epidemics of serogroup B meningococcal disease in recent years, the agency said.

However, the vaccines currently available are effective only for treatment of serogroups A, C, Y and W135, it said, adding that an effective vaccine for serogroup B is not yet available.

A domestic research institution has filed an application for permission to undertake clinical trials for the vaccine aiming to control group B infections, and was approved by the FDA last year for its phase one clinical trial, it said.

The health authority added that last year alone, 157 applications for new drug examinations and registrations were reviewed, of which 122 were approved, a number that made last year the country’s most productive year for approvals in recent history.

Of the approved drugs, those for cancer treatment made up the largest portion, “echoing the fact that cancer is the nation’s leading cause of death and suggesting a desperate need for further development of new drugs that target malignancies,” the agency said.

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