FDA Should Take Action on ‘Unfeasible Guidances’ to Help Boost Stagnant US Antibiotics Market

With a diminishing antibiotics pipeline and one of the primary market needs lying in the availability of effective antibiotics for hospital-acquired pneumonia, FDA needs to take serious action to allow for the introduction of novel innovations in the US market, says an analyst with research and consulting firm GlobalData.

According to Dr Haylyn Wong, GlobalData’s Healthcare Analyst for Cardiovascular and Metabolic Disorders, FDA possesses a long history of having what many consider “unfeasible guidances” for the design of antibiotic clinical trials. As a result, the organisation is now trailing behind the European Medicines Agency (EMA) after the latter released a new addendum to its guideline on the evaluation of medicinal products indicated for treating bacterial infections.

Dr Wong says: “With a strong focus on facilitating the development of antibacterial agents targeted against multidrug-resistant (MDR) pathogens, EMA’s expanded guidance continues to highlight its efforts in developing new antibacterial guidelines that prioritise feasibility.

“Following its release, a trend has now emerged whereby drug companies are encouraged to develop novel antibiotics for the European (EU) market before attempting to gain regulatory approval in the US, which is a detriment to the US market.”

Basilea Pharmaceutica’s antibiotic, ceftobiprole, gained EU regulatory approval in October 2013, where it is now indicated for the treatment of both hospital- and community-acquired pneumonia. Although the company had attempted to gain regulatory approval in the US, its initial rejection by FDA and unsuccessful renegotiations means it is unlikely to continue pushing for this approval.

GlobalData now expects that other drug developers will follow Basilea Pharmaceutica’s example and attempt to register in Europe before approaching the US regulator.

Dr Wong continues: “Despite currently being on the back foot, FDA has made some attempt at catching up to the EMA’s advances in improving the regulatory pathway. Most notably, it published a draft guidance in July, entitled Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious Bacterial Diseases. This called upon sponsors to submit plans and designs for clinical trials.

“However, a stagnant antibacterial pipeline means that FDA still has a lot of hard work ahead, if it wants to ensure that the latest novel antibiotic innovations are not just made available to the EU,” the analyst concludes.