US advisers back Cempra pneumonia antibiotic
US biotech Cempra’s new antibiotic has moved a step closer to market after an FDA committee of advisers narrowly recommended its use against pneumonia.
The FDA’s Antimicrobial Drugs Advisory Committee voted 7-6 that efficacy results of solithromycin outweigh risks of treatment of community-acquired bacterial pneumonia (CABP).
The committee unanimously said there was evidence of efficacy of solithromycin for CABP. But the committee also voted 12-1 that risk of liver damage with solithromycin had not been adequately characterised.
According to Cempra, the committee discussed a variety of approaches to gather more liver safety information on the drug.
The FDA is due to make a regulatory decision on solithromycin by 27 and 29 December, for oral and intravenous uses, respectively.
If approved, solithromycin would be the first new macrolide antibiotic with an oral and IV formulation in over 20 years.
Hedge fund manager Bhavneesh Sharma earlier this year predicted peak sales of $600-650 million in 2025, although others have predicted the figure could be as high as $2 billion.
There has been a dearth of new antibiotics coming to market for around 20 years, as many pharma companies did not want to research them because of low returns on investment.
However some pharma and biotech companies have begun to respond to efforts from governments to encourage their development.
AstraZeneca’s Zavicefta (ceftazidime+avibactam) was approved in Europe earlier this year for treatment of Gram-negative bacterial infections requiring hospitalisation.
Merck & Co bought antibiotics firm Cubist in 2014 for $9.5 billion, which had two antibiotics approved for skin infections and intra-abdominal and urinary tract infections.
In 2012, the FDA approved Janssen’s Sirturo (bedaquiline) for tuberculosis.
Photo courtesy of Public Health Image Library.
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