SECOND QUARTER PRODUCT AND PIPELINE UPDATE
In June, Japan’s Ministry of Health, Labour and Welfare approved the
subcutaneous formulation of Orencia for the treatment of
rheumatoid arthritis in cases where existing treatments are
inadequate. The company co-develops and co-commercializes Orencia
in Japan with Ono Pharmaceutical Co., Ltd.
In June, at the European League Against Rheumatism annual congress in
Madrid, the company presented year two data from the head-to-head
AMPLE study that showed the subcutaneous formulation of Orencia
achieved comparable rates of efficacy and similar onset of response
versus Humira® among biologic-naÏve patients with
moderate to severe rheumatoid arthritis. Overall safety data were
similar for both groups while discontinuations due to adverse events
were higher for Humira.
Bristol-Myers Squibb’s global sales in the second quarter included Yervoy®,
which grew 44%, Onglyza®/Kombiglyze™
, which grew 40%, Sprycel®,
which grew 28%, and Orencia, which grew 21%.
In July, the U.S. Food and Drug Administration (FDA) accepted for
review the Supplemental New Drug Application for Eliquis, for
the prevention of deep vein thrombosis following hip or knee
replacement surgery. The Prescription Drug User Fee Act (PDUFA)
date—the date by which a decision by the FDA is expected—is March 15,
In June, the company and its partner, Pfizer, announced that results
from the Phase III AMPLIFY trial, which evaluated Eliquis
versus the current standard of care for the treatment of acute venous
thromboembolism, were published online by the New England Journal
of Medicine and presented at the International Society on
Thrombosis and Haemostasis congress in Amsterdam. The results showed
that Eliquis demonstrated comparable efficacy and significantly
lower rates of major bleeding compared to the current standard of care.
In May, the company and its partner, Pfizer, announced that results
from a prespecified subanalysis of the ARISTOTLE trial were published
in Circulation, a peer-reviewed journal of the American Heart
Association. The trends across the subgroup analysis were consistent
with the overall study results that demonstrated Eliquis’ superiority
versus warfarin in the reduction of stroke or systemic embolism and
the number of major bleeding events and mortality in patients with
nonvalvular atrial fibrillation.