According to a report by GlobalData, although the Generating Antibiotic Incentives Now (GAIN) Act of 2012 was a step in the right direction for encouraging antibiotics research, FDA still lags behind EMA.
Marc C. Hansel, PhD, GlobalData’s analyst covering infectious diseases, says that the GAIN Act has catalyzed investment from companies in the antibiotics business and has strengthened a stagnant pipeline, with the recent expedited approvals of two new drugs, Sivextro and Dalvance. Although these developments are positive, GlobalData believes that a number of unmet needs remain within the bacterial infectious diseases area, with new treatments for multidrug-resistant (MDR) gram-negative bacteria in particularly high demand.
Despite FDA making advances in incentivizing companies to develop antimicrobial therapies, GlobalData believes that the agency needs to continue taking proactive action if it is to keep pace with progressive regulatory bodies in the EU, particularly the EMA. The latter organization has shown greater willingness to reform clinical trial design for new antibiotics and provide guidance that prioritizes clinical feasibility.
“The FDA will need to continue refining its practices in order to maintain a robust antibiotic pipeline and offer flexibility to encourage the targeting of the most dangerous pathogens. Crucially, the FDA must do more to further draw the vast research and development resources of Big Pharma into the antibiotics market by maximizing its commercial viability,” said Hansel.