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AbbVie's (ABBV) Imbruvica sNDA Gets Priority Review From FDA

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AbbVie Inc. (ABBV - Free Report) announced that the FDA has granted a priority review to its lymphoma drug Imbruvica’s (ibrutinib) sNDA for the treatment of Waldenström's macroglobulinemia (WM) in combination with Rituxan (rituximab), marketed by Genentech, a subsidiary of Roche Group (RHHBY - Free Report) .

The sNDA was based on positive data from the phase III study, iNNOVATE, which evaluated Imbruvica in combination with Rituxan and showed positive outcomes across all lines of WM treatment including patients with untreated and relapsed/refractory WM.

The phase III study (n=150) enrolled patients with relapsed/refractory and treatment-naive WM. Patients received intravenous Rituxan 375 mg/m2 once weekly for four consecutive weeks followed by a second four-weekly Rituxan course post a three-month interval. They either received Imbruvica420 mg or placebo once daily until permanently discontinuing the treatment. The primary endpoint was progression free survival with a measure of safety and tolerability across all treatment lines.

Based on the data and if approved, the sNDA would expand the drug’s label for the indication of WM as the first chemotherapy-free combination treatment option.

Notably, Imbruvica is a first-in-class Bruton's tyrosine kinase inhibitor. The drug is already approved in the United States for the following indications such as chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström's macroglobulinemia along with previously-treated mantle cell lymphoma, previously-treated marginal zone lymphoma and the previously-treated chronic graft-versus-host disease.

The drug is being jointly developed and marketed by Pharmacyclics LLC, which got acquired by AbbVie in 2015 and Janssen Biotech, a unit of Johnson & Johnson (JNJ - Free Report) .

We also mark that AbbVie’s Humira drug is a key growth driver for its revenue base. Imbruvica also appears to have great potential of a blockbuster drug. In the first quarter of 2018, the drug’s net revenues were $762 million, up 38.5% year over year. By the end of the year, its global revenues might exceed $3.3 billion with sales in the United States likely to cross $2.7 billion.

Share of AbbVie has decreased 3.8% year to date compared to the industry’s decline of 4.4%.


AbbVie currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is H Lundbeck A/S (HLUYY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

H Lundbeck’s earnings estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the past 60 days. The stock has soared 42.9% year to date.

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