For FDA, ‘Screaming Unmet Need’ For Antibiotics May Outweigh Significant Safety Concerns
A regulatory panel very narrowly recommended that a new antibiotic be approved for use, even though its structure is similar to an older antibiotic that caused fatal liver injuries.
Will FDA Approve A New Antibiotic Despite 'Significant' Safety Issues?
In a dramatic squeaker, a regulatory panel of experts last Friday narrowly recommended that an antibiotic from Cempra, an upstart developer, should be approved for use. But the 7-to-6 vote suggested an acknowledgement of what one Wall Street analyst calls a “screaming unmet” need for new treatments that outweigh the sort of safety concerns surrounding the product. The meeting was closely watched for two reasons: Cempra pitched solithromycin as an answer to the problem of antibiotic resistance, a huge public health issue. At the same time, the Cempra antibiotic demonstrated a “significant safety signal” and is structurally similar to Ketek, an older antibiotic that caused fatal liver injuries, according to a regulatory review, which was released last Wednesday. (Silverman, 11/7)
In other pharmaceutical news —
Novel Plan To Get Dying Patients A Trial Cancer Drug Raises Questions
The drug was still experimental, but clinical trials suggested it could be a lifesaver for patients with a lethal form of blood cancer called multiple myeloma. And those patients were clamoring to get it. They overwhelmed drug maker Janssen Pharmaceuticals with requests for the medication. Most companies don’t know how to handle such requests. Often, it’s the richest patients, or the best connected, or those who run the most compelling social media campaigns who end up getting the drug. Everyone else is out of luck. (Weintraub, 11/8)
The Wall Street Journal:
Biogen, Ionis Shares Rise After Positive Study Results
Biogen Inc. and Ionis Pharmaceuticals Inc. said their investigational treatment for spinal muscular atrophy showed highly statistically significant improvement in motor function in a phase 3 study of children with late onset cases of the disease. Ionis shares rose 18% to $31.95 and Biogen rose 6% to $293.56 recently in morning trading. So far this year Ionis has dropped 48% and Biogen has declined 4.2%. (Stynes, 11/7)