- Clinical-stage drugmaker Cempra's lead product solithromycin won the backing of an independent advisory committee to the Food and Drug Administration on Friday, but just barely.
- The 13-member Antimicrobial Drugs Advisory Committee voted 7-6 that the benefits of Cempra's treatment for community-acquired bacterial pneumonia (CABP) were greater than the risks. In documents presented to the committee, FDA staff noted that while the drug showed efficacy across clinical trials, it also posed risks to patients' liver health.
- The committee unanimously decided the drug was effective in fighting CABP, yet voted 12-1 that Cempra had not provided enough data to address the potential safety risks associated with solithromycin.
The advisory committee's recommendation of approval for solithromycin, however narrow, is good news for Cempra. The company's share price had fallen more than 60% after the early release of FDA documents highlighting the range of liver damage seen in clinical trial patients.
Still, analysts are skeptical of whether the FDA will agree with the committee's decision when it comes to approving the drug. While the regulator typically follows the advice of its advisory panels, it is not obligated to do so.
Prior to the November 4 meeting, the staff recommended that if Cempra couldn't prove its drug was more effective at treating some CABP patients, combating antibiotic resistant microbes and having fewer adverse effects (outside of liver toxicity) than other treatments, then it initiate further clinical testing.
In that event, the staff advised Cempra to up the number of tested patients from its current 924 to 12,000, and to gather more data on the effects the drug has on liver health.
Cempra has also had difficulty in getting the FDA to approve its manufacturing facility in India.
Jefferies downgraded its rating for Cempra to "Hold" on Monday. Commercial and financial risks, potential new requirements and labels, and an inexact timeline of when the drug will make it to market all contributed to the downgrade, according to the November 7 analyst note.
"While FDA approvability remains a risk, we view potential approval of [solithromycin] as more likely than not with strict post marketing surveillance/additional Ph4 testing," the note said.
Cempra shares were up nearly 9% to $8.22 in early morning trading on Monday.