Johnson & Johnson JNJ announced that a FDA advisory committee has recommended approval of its investigational nasal spray Spravato (esketamine), which has been developed for treatment-resistant depression in adults.
The Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted 14-2 in favor of approval of Spravato stating that the data supports the favorable benefit-risk profile of the nasal spray. If approved, Spravato, which is thought to work differently than currently approved therapies, will be the first new medicine in 30 years to treat this difficult-to-treat mental disease. The FDA’s decision is scheduled on Mar 4. Although the FDA takes the recommendation of the committees in consideration, it is not bound by it.
J&J’s stock has risen 3.3% in the past year compared with an increase of 6.2% recorded by the
J&J filed a new drug application for Spravato in September last year while a regulatory application is also under review in the EU. The NDA was based on five pivotal phase III studies of esketamine nasal spray — three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study — in patients with treatment-resistant depression.
Data from a short-term and a long-term study showed that esketamine nasal spray in combination with newly initiated oral antidepressant (“NIOD”) led to statistically significant , rapid and clinically meaningful reduction of depressive symptoms in patients with treatment-resistant depression.
On the fourth-quarter conference call held last month, J&J management sounded confident that esketamine will get approval in 2019. Another investigational medicine, erdafitinib for metastatic urothelial cancer is also expected to be approved this year. J&J believes that both these medicines have the potential for more than $1 billion of peak revenues.
We remind investors that Spravato is also being developed in phase III studies for major depressive disorder with imminent risk for suicide.
The depression market is quite large and has many players including biggies like Allergan
AGN with products like Vraylar and Viibryd and Eli Lilly ( LLY Quick Quote LLY - Free Report) with Cymbalta and Zyprexa.
In a separate press release, J&J announced that the FDA has granted approval to a split-dosing regimen of its multiple myeloma drug, Darzalex. With the approval, the label of Darzalex has been updated in the United States to allow dosing by splitting the first infusion of Darzalex over two consecutive days. Approval for this split dosing option is likely to improve the administration profile of the medicine. The split-dosing regimen of Darzalex was approved in Europe and Canada in December last year.
J&J currently has a Zacks Rank #3 (Hold). You can see
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