Tagged: US approval

Is Tafenoquine Another Drug Disaster In The Making? ..


When he was interviewed by Evan Davis (of the BBC see here)-  GSK’s (former CEO) Andrew Witty said: ‘On the one hand we have wonder drugs and on the other danger drugs”. What he meant was- the pharmaceutical industry has a bad reputation because some of their drugs released on the market can cause immeasurable harm to unsuspecting patients, while others can no doubt help patients. There are the GSK danger drugs- like Seroxat/Paxil and Avandia, and many more from other pharmaceutical companies- Vioxx being one of the most well known examples..

Will GSK’s Tafenoquine will turn out to be a danger drug or a wonder drug? This remains to be seen.

However, according to Dr Remington Nevin (check him here), GSK’s Tafenoquine is already turning out to be quite the danger drug…

How many people will get neuro-toxic side effects from Tafenoquine when it hits the US market? It looks like we’re just about to find out…

http://www.pharmatimes.com/news/gsk,_mmv_submit_malaria_drug_in_the_us_1212942

 

GSK, MMV submit malaria drug in the US

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GlaxoSmithKline and the Medicines for Malaria Venture are seeking permission to market single-dose tafenoquine in the US to prevent relapse of Plasmodium vivax malaria.

The application, which relates to patients 16 years of age and older, is based on data from the GATHER and DETECTIVE trials.

The Phase III DETECTIVE trial showed that a statistically significant greater proportion of patients treated with single-dose tafenoquine (60 percent) remained relapse-free over the six-month follow-up period than patients on placebo (26 percent).

The GATHER trial investigated a single-dose of 300mg tafenoquine on levels of haemoglobin when compared to a 14-day course of 15mg primaquine, and showed that the incidence of decline “was very low and similar between the two treatment groups”, at 2.4 percent versus 1.2 percent, respectively.

GSK and MMV note that, if approved, tafenoquine would be the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years, “potentially addressing the need for a single-dose and effective medicine for this debilitating disease”.

“One of the greatest challenges for patients with P. vivax malaria is preventing relapses,” said Patrick Vallance, president of R&D at GSK.

“Being able to treat patients with a single dose of medicine would be an important step forward in ensuring efficacious treatment, thereby reducing the risk of relapse, particularly in areas with very limited healthcare infrastructure.”

 

 

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