WHO adds gatifloxacin to prequalification list to encourage API manufacturers

By Gareth Macdonald contact

- Last updated on GMT

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Related tags: Pharmacology

The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.

The World Health Organisation (WHO) added gatifloxacin – the ingredient in Bristol-Myers Squibb’s discontinued antibiotic Tequin – to the prequalification list​ last week, explaining that the aim “is to increase the range and availability of selected APIs.​”

Firms seeking prequalification must submit an active pharmaceutical ingredient master files (APIMF) for WHO review and have their sites inspected. Those that pass are included on a list maintained by the WHO that drug industry customers and regulators can access.

Gatifloxacin was developed by Kyorin. B-MS licensed rights to the ingredient and launched it as Tequin in 1999 as a treatment for respiratory tract infections. The drug was withdrawn in the mid noughties after various studies​ linked it to hypoglycaemia.

Indian authorities later banned the manufacture and sale of drugs containing gatifloxacin, citing​ the ingredient’s side effect profile.

However, the API is still used in various ophthalmic products sold in the US and Canada. In addition it is sold in solid dosage form drugs in China.

TB battle

The WHO’s bid to encourage gatifloxacin production are in keeping with the conclusions of a report​ it published last week criticising governmental and drug industry efforts to tackle tuberculosis (TB).

Mario Raviglione, Director of the WHO Global TB Programme, warned that TB reduction targets agreed at the United Nations General Assembly will not be met without a significant increase in investment in drug development.

The dismal progress in the TB response is a tragedy for the millions of people suffering from this disease. To save more lives now, we must get newly recommended rapid tests, drugs and regimens to those who need them.  Current actions and investments fall far short of what is needed​.”

The WHO estimated that an extra $1bn (€909m) per year is needed to accelerate the development of new vaccines, diagnostics, and medicines.

Risk-based assessment

Daniela Bagozzi, WHO senior information manager, told us encouraging gatifloxacin production will increase the availability of drugs for resistant TB and added that concerns about the API's side effects do not apply when it is used to treat otherwise untreatable infections.

"WHO prequalification of medicines issues expressions of interest for APIs or finished products that tackle priority conditions from a global public health perspective. The safety issues related to gatifloxacin are only relevant in the context of use for relatively trivial infections. We are talking about its use for MDR TB where the risk-benefit assessment is completely different​."

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