Faster Approval Procedures Urged For New TB Drugs

by Malathi Raman on  October 31, 2006 at 12:41 PM Research News   - G J E 4
Faster Approval Procedures Urged For New TB Drugs
Medicins Sans Frontiers(MSF), on Monday called for fast tracking of the approval procedures for drugs which are likely to be effective against extremely drug resistant tuberculosis(XDR-TB) which is highly prevalent, especially in sub Saharan Africa.

MSF otherwise called Doctors Without Borders(DWB) has urged that the regulatory bodies like the US Food and Drug Administraton(USFDA) and European Medicines Agency step up their pace in developing the promising drugs and make them available.

It was thought earlier that TB had been contained and its eradication was only a matter of time. But the respiratory disease is now back in the form of a new virulent drug resistant strain. The World Health Organization(WHO) estimates that nearly 2 million people worldwide die of TB each year, 99% of them from developing countries.

People with HIV/AIDS are likelier to be susceptible to it because of their low immunity levels and one third of them are infected with TB.

Around 450,000 people are infected yearly with strains that resist treatment with first-line antibiotics, and an increasing number are also untreatable with second-line drugs, "making treatment with existing drugs virtually impossible," MSF said.

The head of Doctors Without Borders, Rowan Gillies, said that research into TB drugs has not been a priority for the past 40-50 years, and that the WHO should take the initiative to deal with this crisis immediately.

The first of the drugs in the pipeline is not going to be ready before 2010 at the current speed of operations, and others will be even more delayed.

Three other medicines are now in clinical trials -- Johnson & Johnson's Diarylquinoline, Otsuka's Nitroimidazo, and Pyrrole by Lupin Ltd and Tido von Schoen-Angerer, director of MSF's Campaign for Access to Essential Medicines, said that it is important that they be brought to the market quickly.

He said fast-tracking the three drugs could help curb the spreading of the difficult strains and urged the WHO to ensure adequate funding into TB research. He suggested that just as the first HIV drugs were made available even before final approval, the new TB drugs be given to the needy patients as soon as they were proven safe.

Source: Medindia

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