Pharmaceutical history - October 27th

In October  27th 1999 the FDA approved as a new molecular entity the active pharmaceutical ingredient Oseltamivir, under the trade name Tamiflu, manufactured by the pharmaceutical company Roche.

Oseltamivir is a synthetic prodrug with antiviral activity. By blocking neuraminidases on the surfaces of influenza viruses, oseltamivir interferes with host cell release of complete viral particles.

Oseltamivir was discovered by scientists at Gilead using shikimic acid as a starting point for synthesis; shikimic acid was originally available only as an extract of Chinese star anise; but by 2006, 30% of the supply was manufactured recombinantly in E. coli. Gilead exclusively licensed their relevant patents to Roche in 1996.

In 1999, the FDA approved oseltamivir phosphate for treatment of influenza in adults based on two double-blinded, randomized, placebo-controlled clinical trials. In June 2002 EMA approved oseltamivir phosphate for prophylaxis and treatment of influenza. In 2003 a pooled analysis of 10 randomised clinical trials concluded that oseltamivir reduced the risk of lower respiratory tract infections resulting in antibiotic use and hospital admissions in adults.

Oseltamivir (as Tamiflu) was widely used during the H5N1 avian influenza epidemic in Southeast Asia in 2005. In response to the epidemic, various governments – including those of the United Kingdom, Canada, Israel, United States, and Australia.

In 2006, a Cochrane review raised controversy by concluding that oseltamivir should not be used during routine seasonal influenza because of its low effectiveness.

Source https://en.wikipedia.org/wiki/Oseltamivir#History

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