On its first-quarter earnings conference call, AbbVie (ABBV) guided for 2019 global sales of $1.1 billion for Imbruvica. According to Evaluate Pharma’s World Preview 2019 report, AbbVie and Johnson & Johnson’s (JNJ) Imbruvica is expected to become the fifth-highest-selling pharmaceutical product in the world by 2024. The drug’s revenue is expected to increase at a compound annual growth rate of 13.5% from 2018 to $9.51 billion in 2024.
On January 28, AbbVie issued a press release announcing the FDA’s approval of its chemotherapy-free Imbruvica-Gazyva combination regimen in front-line CLL (chronic lymphocytic leukemia) indications. According to the company’s first-quarter earnings conference call, this is the tenth approved indication for Imbruvica, and it’s based on the results of the pivotal Phase 3 iLLUMINATE trial. The National Comprehensive Cancer Network has recommended Imbruvica as the only Category 1 Preferred Regimen for first-line CLL patients.
In the first quarter, Imbruvica reported global sales of $1.02 billion, a YoY rise of 34% on an operational and a reported basis. According to the company’s first-quarter earnings conference call, Imbruvica sales in the US contributed ~$829 million to its revenue, a YoY rise of 32.8%. Imbruvica earned $193 million in revenue in international markets, a YoY rise of 39.6%.
At the end of the first quarter, Imbruvica was the dominant player across all lines of CLL therapy, and it accounted for a 25% new patient share of the first-line CLL market.
In the first quarter, Venclexta reported global sales of $151 million, $105 million of which came from the US market and $46 million of which came from international markets. According to the company’s first-quarter earnings conference call, this performance was mainly driven by solid uptake in relapsed and refractory CLL and ongoing first-line acute myeloid leukemia indications. AbbVie is awaiting the FDA’s decision on Venclexta in front-line CLL indications in late 2019.
However, Venclexta’s research and development program saw a setback on March 19 as the FDA placed a partial clinical hold on trials evaluating the drug in relapsed and refractory multiple myeloma indications. This decision was made after a large number of deaths were noted in the Phase 3 BELLINI trial for patients on Venclexta compared to those on the placebo.