AbbVie (ABBV) has continued to expand the approved indications for Imbruvica in 2016. The drug can be successfully used across all lines of therapy for CLL (chronic lymphocytic leukemia) as well as for SLL (small lymphocytic leukemia). Wall Street analysts expect Imbruvica’s revenues to reach $1.8 billion in 2016, which would represent a YoY (year-over-year) growth of about 139%.
Imbruvica is thus expected to help AbbVie reduce its overreliance on Humira’s sales and to account for about 7% of the company’s total revenues in 2016.
The above diagram shows that there is significant unmet demand and hence market opportunities for Imbruvica in CLL and NHL (non-Hodgkin’s lymphoma). Despite effective standards of care, both CLL and NHL patients currently witness reduced survival rates as well as overall life expectancy.
To date, Imbruvica has managed to treat approximately 10,500 patients in clinical trials and 35,000 patients in the real world.
Clinical trial results
Imbruvica is expected to become a leading therapy for treatment-naive CLL patients over 65 years of age, as demonstrated in the Resonate-2 study, wherein the drug’s efficacy was compared with the traditional chemotherapy Chorambucil. The data obtained from this trial demonstrated that the use of Imbruvica as front-line CLL therapy resulted in a 91% decline in risk of disease progression or death. Imbruvica also displayed benefits in overall survival numbers.
Imbruvica has been awarded a Category One designation, which is the highest recommended position for CLL by the NCCN (National Comprehensive Cancer Network). Imbruvica is thus expected to pose strong competition to other hematologic oncology drugs such as Novartis’s (NVS) Farydak, Celgene’s (CELG) Revlimid, and Amgen’s (AMGN) Kyprolis.
Imbruvica also obtained a positive opinion from Committee for Medicinal Products for Human Use in April 2016. The drug is currently being reviewed by European Medicines Agency to be approved as a first-line therapy for CLL. If approved, Imbruvica could boost AbbVie’s revenues and impact the First Trust US IPO Index Fund (FPX), which has an exposure of about 9.1% to AbbVie.
Now let’s explore the ongoing research programs for Imbruvica.