EMA recommends approval of new antibiotic combination to treat multi-drug resistant bateria (even though with a but)

So the European Medicines Agency  on the 26th of April 2016 recommended the approval of ceftazidime/avibactam (jountly developed by AstraZeneca and Allergan) combination for 'marketing' authorization as an option for treating multidrug resistant bacteria.

Even though 'data' to support the authorization is limited. The EMA went ahead to give this approval on the basis that the drug targets pathogens in areas where treatment are needed.

Now this raises a very serious concern to me, cos am certain the limited data would be in the area of extensive Clinical Trials (Phase 1-4 ) and secondly these areas where the "treatment are needed" would be Africa, sub Saharan Africa to be precise. Let's not be in a hurry to forget the infamous Trovan Tragedy that happened in Kano around  1996.

While multidrug resistant pathogens poses a great threat to pharmacotherapy, and needs critical attention especially in this region, thats not a good enough basis for a speedy approval without enough data to support such. I call on our drug regulatory bodies (NAFDAC in Nigeria, FDA in Ghana and so on ) to close scrutinise new drugs coming into the region and conduct or supervise independent trials rather than rely on European and American so called standards. After all it seems we are at the receiving end of the bitter pill. My thougths.

Please continue reading.....

The new intravenous combination product is made up of avibactam, a new beta-lactamase inhibitor, and ceftazidime, a third generation cephalosporin that is already approved for use in the EU.

The EMA says that resistance to cephalosporins and to another class of antibiotics, carbapenems, has been increasing lately, particularly in Gram-negative bacteria, and is of major concern.

The new combination drug works by inhibiting the action of beta-lactamase enzymes, thereby restoring the activity of ceftazidime against ceftazidime-resistant pathogens. It also acts against many of the carbapenem-resistant Enterobacteriaceae.

The recommendation from the EMA’s Committee for Medicinal Products for Human use (CHMP) now goes before the European Commission for approval. It will then be up to individual member states to decide whether to make the drug available within their own health service.

The EMA recommendation comes 14 months after the US Food and Drug Administration approved the same drug combination, marketed as Avycaz, for similar indications.

Refrence: the Pharmaceutical Journal