FDA Approves Rituxan and Steroid for Severe Vasculitis
Genentech and Biogen Idec have announced that the
FDA approved Rituxan (rituximab), in combination with
corticosteroids, as a new medicine for adults with Wegener's
Granulomatosis (WG) and Microscopic Polyangiitis (MPA).
The approval is based on a National Institutes of Healthsponsored
study known as RAVE (Rituxan in ANCA-Associated
Vasculitis) that showed Rituxan to be comparable to the current
standard of care, cyclophosphamide (CYC), in inducing disease
remission at six months in adults with WG and MPA. RAVE is a
multicenter, randomized, double-blind, active-controlled study.
In the study, patients were randomized to receive either Rituxan
for four weeks with corticosteroids, or the control treatment of
oral CYC with corticosteroids daily for three to six months in
the remission induction phase. Once remission was achieved
or at the end of the six-month remission induction period,
patients in the CYC group were to receive daily azathioprine
to maintain remission. Patients in the Rituxan group were
not to receive additional therapy to maintain remission. In
the Rituxan group, 64 percent (63/99) of patients reached the
primary endpoint of complete remission at six months, defined
as a zero score on the Birmingham Vasculitis Activity Score
for Wegener's Granulomatosis (BVAS/WG) and successfully
tapered off corticosteroids, compared with 53 percent (52/98) of
patients who received CYC with corticosteroids. The BVAS/WG
is an instrument used in clinical trials to define and measure
worsening or improvement of AAV disease activity among
patients.
Infections were the most commonly reported adverse events
and occurred in 62 percent (61/99) of patients in the Rituxan
group and 47 percent (46/98) of patients in the control group
and were most frequently upper respiratory tract infections.
The study evaluated specific serious adverse events of concern
in this patient population including deaths, development
of certain forms of cancers, blood disorders, infections,
cardiovascular events, hospitalizations and infusion reactions.
At six months, 33 percent (n=32) of those taking CYC developed
one of the adverse events versus 22 percent (n=22) of those on
Rituxan.
LEO Pharma Launches $0 Copay Program for Taclonex Plaque Psoriasis Treatments
LEO Pharma has launched a $0 copay program for its plaque
psoriasis treatments, Taclonex Ointment and Taclonex Scalp.
Patients can now obtain a patient savings card via their
healthcare provider or at the taclonex website that can be
presented along with their prescription to cover their copay
costs. The program offers eligible patients copay assistance for
up to six prescriptions with a maximum benefit of $200 off per
prescription. There is no activation required, and the card is valid
until December 31, 2012, with some applicable restrictions.
Psoriasis is a non-contagious, chronic disease of the immune
system that affects an estimated 125 million people worldwide.
Plaque psoriasis generally appears as patches of raised, red
skin covered by flaky white buildup of dead skin cells. These
patches most often appear on the scalp, knees, elbows and
torso, are often itchy and painful, and can crack and bleed.
Taclonex (calcipotriene 0.005% and betamethasone dipropionate
0.064%) Ointment is approved for use on the skin to treat psoriasis
vulgaris (plaque psoriasis) in adults 18 years of age and older and
should be applied to affected areas once daily for up to four weeks.
Taclonex Scalp (calcipotriene 0.005% and betamethasone
dipropionate 0.064%) Topical Suspension is approved to treat
moderate-to-severe psoriasis vulgaris of the scalp in adults 18 years
and older and should be applied to affected areas on the scalp once
a day for two weeks or until cleared. If the affected area is not
cleared, Taclonex Scalp Topical Suspension may be continued for
up to eight weeks, not exceeding the recommended weekly dose of
100 grams. Neither product is recommended for use on children.
Taro Receives FDA Approval for Imiquimod Cream, 5%
Taro Pharmaceutical Industries Ltd. has received approval from
the FDA for its Abbreviated New Drug Application (ANDA) for
Imiquimod Cream, 5%.
Taro's imiquimod cream is a prescription pharmaceutical
product used for topical treatment of actinic keratosis and
external genital warts and is bioequivalent to Aldara Cream,
5% of Graceway Pharmaceuticals, LLC.
