Yahoo Finance AbbVie (ABBV) Vraylar Gets FDA Nod for Major Depressive Disorder
AbbVie ABBV announced that the FDA has approved Vraylar (cariprazine) for the adjunctive treatment of patients with major depressive disorder (MDD).
Vraylar is presently approved for treating schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and depressive episodes associated with bipolar I disorder. MDD is the fourth indication for Vraylar. Vraylar is now the only dopamine and serotonin partial agonist approved by the FDA to treat the most common forms of depression, which are as an adjunctive treatment for MDD and the treatment of depressive episodes associated with bipolar I disorder.
About one in five U.S. adults will experience MDD, a common mental disorder, during their lifetime. Several MDD patients experience partial response to their antidepressant therapy as they still have depressive symptoms. The approval of Vraylar for MDD offers a new adjunctive treatment option for these patients.
The supplemental new drug application (sNDA) seeking approval of Vraylar for MDD was based on data from two phase III studies.
Vraylar is co-developed by AbbVie and Gedeon Richter. The drug generated sales of $1.47 billion for AbbVie in the first nine months of 2022. With the approval for the MDD indication, sales are expected to be higher in future quarters.
AbbVie’s stock has risen 16.0% this year so far compared with an increase of 14.1% for the industry.
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AbbVie also announced that it has submitted a sNDA to the FDA seeking approval of Linzess for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC).
Linzess is developed and marketed by AbbVie and Ironwood Pharmaceuticals IRWD. Ironwood Pharmaceuticals and AbbVie share equally in U.S. brand collaboration profits. The IRWD-partnered drug is approved to treat adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C).
The sNDA seeking approval for FC is based on positive data from a phase III study which showed that Linzess (72mcg) led to increases in the frequency of spontaneous bowel movements (SBM) and improved stool consistency in pediatric patients (6 to 17 years).
Zacks Rank & Stock to Consider
AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked large drugmakers are Sanofi SNY and Gilead Sciences GILD, both carrying a Zacks Rank #2 (Buy) at present.
Sanofi’s earnings per share estimates for 2022 have increased from $4.01 per share to $4.16 while that for 2023 has jumped from $4.22 per share to $4.31 in the past 30 days. Sanofi’sstock is down 6.2% in the year-to-date period.
Sanofi beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 9.50%, on average.
Estimates for Gilead’s 2022 earnings per share have increased from $6.57 per share to $7.09, while that for 2023 have jumped from $6.48 per share to $6.78 in the past 30 days. Gilead’s stock is up 19.4% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.
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