J&J nears FDA approval for landmark depression drug to replace ketamine treatments
Johnson & Johnson is on the cusp of receiving federal approval for a potentially blockbuster drug to treat depression that could replace the costly and time-intensive ketamine treatments that some individuals turn to amid a lack of new options from top pharmaceutical companies.
The drug – known as esketamine – won backing on Tuesday from an outside panel of experts convened by the Food and Drug Administration. The agency is expected to decide by early March whether to approve it for commercial sale in the U.S., a move that could also lead to a slew of follow-on treatments that promise faster cures for depression without the detrimental side-effects that come with existing drugs.
“Expectations should start to change,” VistaGen Therapeutics CEO Shawn Singh, a company developing its own drugs to treat depression and social anxiety, told Fox Business. “You really need big pharma’s muscle to say to Wall Street this is worthy of your attention.”
The existing options to treat depression are decades old, often come with harsh side effects and don’t adequately treat all patients. Prozac, for example, was approved in 1986 and can lead to weight gain and lower sex drive.
Ketamine – an anesthetic that is also popular among recreational drug users – has emerged as an alternative, but each IV drip to administer the treatment can cost upwards of $750 and last as long as two hours. It is also not formally approved by the FDA to treat depression.
J&J’s drug mimics the effects of ketamine in a nasal spray bottle. Both act much quicker than traditional anti-depressants – which can take weeks to work patients – and have similar side effects, namely a feeling of dissociation from one’s body.
Should it approve the drug, the FDA is expected to put a strict risk evaluations and mitigation strategy (REMS) program on it. The system is used to place restrictions on drugs that have certain threats that could hinder the overall benefits. In J&J’s case, the agency recommended that patients who use esketamine be monitored by a physician for two hours after taking the drug.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| JNJ | JOHNSON & JOHNSON | 155.15 | -0.34 | -0.22% |
The New Brunswick, N.J.-based company is banking on esketamine to be a big money-maker for the firm – potentially as much as $1 billion in peak revenue, CEO Alex Gorsky recently told investors.
While J&J manufactures a huge range of products, from medical devices, to drugs and consumer goods, the pharmaceutical division continues to make-up for losses in other sectors. Its drug sales grew 12.4 percent to $40.7 billion worldwide in 2018.
The expected approval comes as J&J faces legal and public backlash over media reports that several of its popular powder-based products contained cancer-causing asbestos, a claim the company vigorously denies.
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And amid continued pressure on high drug costs from the Trump administration and Congress, J&J recently became the first drugmaker to agree to list the price of treatments in direct-to-consumer advertisements.