FDA Pushes Back On Claims Made For Unapproved Covid Antibody Drug
The covid antibody drug leronlimab had been publicly promoted for saving lives by maker CytoDyn, but the FDA's statement says it's not so. Meanwhile, a more powerful naloxone version is on the way. And Congress prepares to question the CEO of AbbVie over drug pricing.
FDA Issues Major Rebuke To CytoDyn Over Claims On Covid-19 Drug
The Food and Drug Administration on Monday took the extraordinary step of issuing a lengthy statement on an unapproved drug, rejecting claims made by the troubled drug maker CytoDyn about its failed antibody treatment for Covid-19. CytoDyn’s CEO, Nader Pourhassan, has repeatedly touted the potential of the drug, leronlimab, on conference calls, YouTube videos, and in press releases, saying the treatment was shown to have saved lives in clinical trials. The FDA said it had determined otherwise. (Feuerstein, 5/17)
In other pharmaceutical industry news —
Congress Is Ready To Grill AbbVie’s CEO Over Drug Pricing
AbbVie CEO Richard Gonzalez is in for a congressional tongue-lashing of outsized proportion. And it couldn’t come at a worse time. Just two years ago, AbbVie seemed on the verge of serious financial trouble. Now, investors are openly proclaiming the pharma giant as one of their favorite stock picks. AbbVie exceeded its projected earnings last month, even while other pharma giants like Merck fell short. Its stock is trading near a 52-week high. (Florko, 5/18)
Cel-Sci CEO's Remarks To Investors Raise Doubts On Cancer Drug
Cel-Sci CEO Geert Kersten spoke privately with investors last week as part of a “non-deal roadshow” organized by Kingswood Capital Markets, an investment bank that has helped the drug maker raise money in the past. The timing of the meetings is curious, given that more than one year has passed since Cel-Sci completed a Phase 3 clinical trial of its cancer immunotherapy Multikine. As I wrote recently, the only logical explanation for burying results this long is to put off admitting the study’s failure. Multikine does not work. (Feuerstein, 5/17)
In updates on the opioid crisis —
Drug Company Exec Says System Of Checks And Balances Goes Beyond What Law Requires
An executive for AmerisourceBergen Drug Co. said its system of checks and balances to prevent diversion of opioids into the illicit market goes beyond what regulation calls for, but the public was unable to fully view the system during trial Monday. The trial, taking place before Senior U.S. District Court Judge David Faber at the Robert C. Byrd U.S. Courthouse in Charleston, is based on allegations made by Cabell County and Huntington against the “Big Three” drug wholesalers of sparking the opioid crisis by sending 127.9 million opiate doses into Cabell County from 2006-2014. A reduction in the amount of pills shipped led opioid users to turn to illicit drugs, they said. (Hessler, 5/17)
The Washington Post:
A More Powerful Naloxone Is On The Way. The Question Is Whether It’s Needed.
With deaths from opioids soaring again, the Food and Drug Administration last month approved a more powerful version of the fast-acting antidote naloxone, an emergency medicine that restores breathing halted by overdoses of fentanyl, heroin or oxycodone. ... But there is widespread disagreement about the value of more potent naloxone. Some research shows that more than 4 milligrams is seldom needed. Some experts and harm reduction advocates, who work to reduce death on the streets, said the decision was driven by false beliefs that the increasing potency of illegal fentanyl requires a stronger antidote and by the marketing strategy of the drug company, Hikma Pharmaceuticals. Some are concerned stronger naloxone could cause harm by precipitating intense, rapid withdrawal from opioids. (Bernstein, 5/17)