J&J drug passes muster with FDA advisory committee

Drug for Depression

On February 12 Johnson & Johnson’s the intranasally administered antidepressant, esketamine, was reviewed by an FDA advisory committee. The committee voted overwhelmingly in favor of the ketamine-like drug, in spite of the shortcomings of its clinical program. Although not all of J&J’s studies supported the drug, it now seems that J&J will garner approval for what some experts see as “one of the most notable antidepressants in decades,” according to Phil Taylor of Fierce Biotech.

FDA approval would make esketamine one of the first new approaches for treating refractory major depressive disorder (MDD) in the last 50 years. It would give millions of people who struggle to control symptoms in spite of drug therapy a new option. Currently, only one drug is FDA-approved for treatment-resistant MDD.

Esketamine is envisioned as an add-on therapy to oral antidepressants. In 2018 J&J reported the results of two phase 3 studies of the drug. A study in adults with treatment-resistant MDD demonstrated that the drug was more effective than placebo in relieving symptoms. Conversely, a second study in patients 65 or older failed to meet the threshold for significance, but J&J said it had a “clinically meaningful” impact.

J&J has picked up a pair of breakthrough therapy designations from the FDA, showing the great need for new treatment options for depression. J&J expects esketamin to have $1 billion-plus sales potential. The FDA appears to have a favorable view of esketamine’s safety profile, especially because there is not a higher rate of cognitive impairment or liver injury with the drug relative to placebo, unlike parent drug ketamine. The FDA also claims that none of the six deaths in the treatment arms of the studies appear to be drug-related. Financial analysts noted that the “somewhat unexpected interpretation” of that data “lays a positive foundation” for approval.

Because two of the three pivotal trials J&J ran to assess the short-term effects of esketamine missed their primary endpoints, results from one of the short-term studies and data generated in a maintenance trial formed the basis of J&J’s case for the efficacy of esketamine. Although panelists wondered if approving a drug that failed two out of three trials would set a bad precedent, they decided that the benefits of esketamine outweigh the risks in the target population.

The reason for the approval has much to do with the unmet need. Recently, physicians have resorted to using ketamine off-label as there is a lack of approved, fast-acting depression drugs. According to Fierce Biotech, “With a body of evidence beyond the esketamine trials suggesting ketamine works fast?—?and the maintenance trial finding positive effects are sustained?—?J&J’s case was compelling enough to get it over the line.”

Now the application will advance to the FDA, which will decide whether to approve the drug. Because of the frequency with which the FDA follows committee recommendations and the content of its briefing notes on esketamine, it seems as if the drug will get approved by the agency.Drug for Depression

On February 12 Johnson & Johnson’s the intranasally administered antidepressant, esketamine, was reviewed by an FDA advisory committee. The committee voted overwhelmingly in favor of the ketamine-like drug, in spite of the shortcomings of its clinical program. Although not all of J&J’s studies supported the drug, it now seems that J&J will garner approval for what some experts see as “one of the most notable antidepressants in decades,” according to Phil Taylor of Fierce Biotech.

FDA approval would make esketamine one of the first new approaches for treating refractory major depressive disorder (MDD) in the last 50 years. It would give millions of people who struggle to control symptoms in spite of drug therapy a new option. Currently, only one drug is FDA-approved for treatment-resistant MDD.

Esketamine is envisioned as an add-on therapy to oral antidepressants. In 2018 J&J reported the results of two phase 3 studies of the drug. A study in adults with treatment-resistant MDD demonstrated that the drug was more effective than placebo in relieving symptoms. Conversely, a second study in patients 65 or older failed to meet the threshold for significance, but J&J said it had a “clinically meaningful” impact.

J&J has picked up a pair of breakthrough therapy designations from the FDA, showing the great need for new treatment options for depression. J&J expects esketamin to have $1 billion-plus sales potential. The FDA appears to have a favorable view of esketamine’s safety profile, especially because there is not a higher rate of cognitive impairment or liver injury with the drug relative to placebo, unlike parent drug ketamine. The FDA also claims that none of the six deaths in the treatment arms of the studies appear to be drug-related. Financial analysts noted that the “somewhat unexpected interpretation” of that data “lays a positive foundation” for approval.

Because two of the three pivotal trials J&J ran to assess the short-term effects of esketamine missed their primary endpoints, results from one of the short-term studies and data generated in a maintenance trial formed the basis of J&J’s case for the efficacy of esketamine. Although panelists wondered if approving a drug that failed two out of three trials would set a bad precedent, they decided that the benefits of esketamine outweigh the risks in the target population.

The reason for the approval has much to do with the unmet need. Recently, physicians have resorted to using ketamine off-label as there is a lack of approved, fast-acting depression drugs. According to Fierce Biotech, “With a body of evidence beyond the esketamine trials suggesting ketamine works fast?—?and the maintenance trial finding positive effects are sustained?—?J&J’s case was compelling enough to get it over the line.”

Now the application will advance to the FDA, which will decide whether to approve the drug. Because of the frequency with which the FDA follows committee recommendations and the content of its briefing notes on esketamine, it seems as if the drug will get approved by the agency.

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