New hope for MDR-TB patients
5 August 2014 - The USAID-supported Promoting Quality of Medicines (PQM) Program in collaboration with the Global Drug Facility (GDF) has helped attain WHO Pre-Qualification Program (PQP) approval for two important second-line TB drug products. The prequalification of Capreomycin and Levoflaxacin Active Pharmaceutical Ingredients (APIs) is a significant win in the global fight against TB. This new development will save many more lives from multi-drug resistant TB (MDR-TB) by increasing the quality and availability of TB medicines and also bringing about a reduction in price. These quality assured drugs are available through the Global Drug Facility (GDF) to countries to support their fight against MDR-TB.
USAID’s TB program has played a critical role in improving
the availability, quality and affordability of drugs to treat
MDR-TB for over six years. Mapping out the vulnerabilities of
second-line drug supply chains with GDF and its partners is a
key step to ensuring that a broader base of APIs and finished
products is available to address the challenges of supply
security and to promote a safer market where competition can
further bring prices down. Substandard and counterfeit medicines
can pose a dangerous public health threat in developing
countries, where the lack of financial and technical resources
make it already challenging to protect drug supply chains. This
is especially true for TB, where drug quality is an important
factor in the increasing emergence of multi-drug resistance.
An inadequate supply of quality-assured second-line
TB medicines remains a major challenge in combating MDR-TB. To
expedite the process of pre-qualification with WHO or support
the process of medicines registration with Stringent Regulatory
Authorities, thereby expanding the pool of manufacturers,
USAID’s PQM program provides technical assistance to
interested manufactures on the preparation of product dossiers
for submission to WHO; makes suggestions on improving good
manufacturing practices, including bio-equivalence studies and
other product improvements; and conducts site visits as
necessary to achieve WHO PQP certification.
As a
result of these efforts, Capreomycin is the first second-line
injectable anti-tuberculosis drug in the treatment of MDR-TB to
attain prequalification status from WHO. With the increasing
availability of this important drug, it is anticipated that the
cost of the medicine will decrease significantly, thus making it
more affordable.
Levofloxacin, another medicine
currently in high demand as a TB drug, will also become more
available and affordable for TB patients following this
development. It is the 3rd second-line TB drug, in addition to
Capreomycin and Cycloserine, that USAID’s PQM program has
helped achieve WHO prequalification.
“The
availability of WHO quality-assured TB drugs is essential for
avoiding the emergence of further drug resistance and saving
lives,” says Cheri Vincent, chief of the Infectious
Diseases Division at USAID’s Global Health Bureau.
“USAID’s PQM program is helping expand access to
quality medicines to people with the greatest need.”
Source:
Stop TB Partnership
