WHO invites applications from drug companies for pre qualification of MDR TB drugs
MUMBAI: The World Health Organization on Wednesday invited drug companies to submit expression of interest to manufacture Bedaquiline and Delamanid-- the two new drugs for treating multi drug resistant Tuberculosis.
Bedaquiline, sold under the brand name Serturu by Janseen (a subsidiary of Johnson & Johnson), and Delamanid, sold by Japanese drug maker Otsuka, are two of the new TB drugs approved by the US Food and Drug Administration and European Medicine Agency after 40 years.
"The ultimate aim of this Express of Interest is to increase the range of selected products and sources available in relation to treatment for TB", the WHO said.
"The recommended active ingredients, dosage forms and strengths listed in this document have been identified by WHO's Global TB Programme for effective treatment of people suffering from TB", the statement added.
WHO said the expression of interest will be evaluated on the basis of product dossiers, which must include product data and information as specified in the guidelines for submission, manufacturing sites which must adhere to Good manufacturing practices and clinical sites.