Top FDA Regulator Publicly Questions Safety and Efficacy of Lupus Drug Voclosporin, Rattling Investors
WASHINGTON – A rare public rebuke from a top Food and Drug Administration regulator regarding voclosporin, a drug approved in 2021 to treat lupus nephritis, has sparked concern on Wall Street and raised questions about the agency’s post-approval monitoring of medications. Dr.Binoy Prashant, the FDA’s acting director of the division of transplant and immunology, took to LinkedIn to express “notable” concerns about the drug’s toxicity and questioned whether it provides a “direct clinical benefit” to patients.
The unusual public criticism,reported initially by STAT News,comes as Aurinia Pharmaceuticals,the company that markets voclosporin,faces increasing scrutiny over the drug’s performance and safety profile. Lupus nephritis is a serious autoimmune disease causing kidney inflammation, affecting an estimated 20% of lupus patients. Voclosporin’s approval offered a new treatment option, but Dr. Prashant’s comments suggest the FDA may be re-evaluating the risk-benefit profile of the medication, possibly impacting future sales and the company’s stock price.
Aurinia’s stock price dropped sharply following reports of Dr. Prashant’s post, reflecting investor anxiety. The FDA rarely publicly criticizes approved drugs, typically addressing concerns through internal channels or direct communication with the pharmaceutical company. Dr. Prashant’s decision to voice his concerns on a public platform is considered highly unusual and signals a potentially deeper level of concern within the agency.
Voclosporin, a calcineurin inhibitor, works by suppressing the immune system. While it demonstrated efficacy in clinical trials, concerns about its potential side effects, including kidney damage and increased risk of infection, have persisted. the drug carries a boxed warning, the most serious type of warning issued by the FDA, highlighting these risks.
The FDA confirmed the authenticity of Dr. Prashant’s post but declined to comment further, citing the agency’s policy of not discussing individual drug reviews publicly. Aurinia pharmaceuticals defended voclosporin, stating the drug has been shown to reduce kidney damage in lupus nephritis patients and that the company is committed to monitoring its safety. The company also noted that the drug’s label includes extensive safety facts.
