Galderma Receives FDA Approval of Treatment for Rosacea
Galderma Laboratories, L.P. has announced that the FDA has approved
Galderma’s Soolantra® (ivermectin) Cream, 1% for the
once-daily topical treatment of inflammatory lesions of rosacea.
The approval of Soolantra Cream was based on two pivotal
phase 3, multicenter, randomized, doubleblind, 12-week, vehicle-
controlled, parallel-group studies where Soolantra Cream
met each of its coprimary efficacy endpoints. The onset of treatment
effect was observed as early as week two with continuous
improvement. In long-term extensions to the 12-week studies,
Soolantra Cream was also safe and well-tolerated for an additional
40 weeks. Some study subjects experienced skin burning
sensation and skin irritation while using Soolantra Cream.
Galderma also reports that in a separate head to head study
with metronidazole 0.75% cream Soolantra Cream was shown
to be more efficacious from as early as week three onwards.
FDA Approval of ONEXTON
Valeant Pharmaceuticals International, Inc. has announced that
it has received approval from the FDA for ONEXTON™ Gel
(clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for
the once-daily treatment of comedonal (non-inflammatory) and
inflammatory acne in patients 12 and older. ONEXTON™ Gel
has a favorable cutaneous tolerability profile and contains no
surfactants, alcohol or preservatives.
Valeant has touted the results of a pivotal trial with 498 patients
with moderate to severe acne in which efficacy was assessed at
week 12. ONEXTON™ Gel reduced non-inflammatory lesions
by a mean of 52% vs. 28% vehicle, for mean absolute reductions
of 19 vs. 10, respectively. ONEXTON™ Gel also reduced
inflammatory lesions by a mean of 60% vs. 31% vehicle, for
mean absolute reduction of 16 vs. 8, respectively. In addition,
the proportion of patients experiencing treatment success in
the ONEXTON™ group was twice that of vehicle (35% vs. 17%).
Treatment success was defined as at least 2 grade improvement
in the Evaluator Global Severity (EGS) score from baseline.
In the controlled clinical trial, according to Valeant, less than 1%
of patients experienced a treatment related adverse event. The
most common treatment-emergent and treatment-related adverse
events were: burning sensation (0.4%), dermatitis contact
(0.4%), pruritus (0.4%) and rash (0.4%). No ONEXTON™ patient
had their treatment discontinued due to any adverse event.
CellCept Generic Released
Ascend Laboratories has launched its AB-rated generic version
of Genentech’s CellCept (mycophenolate mofetil) oral suspension,
for the prophylaxis of organ rejection in patients receiving
allogeneic renal, cardiac, or hepatic transplants. CellCept®
(mycophenolate mofetil). Generic CellCept oral suspension
will be available as a dry powder that provides 200 mg of mycophenolate
mofetil per milliliter after reconstitution.
Ascend advises that CellCept should be used concomitantly
with cyclosporine and corticosteroids. CellCept carries a boxed
warning regarding the risk of embryofetal toxicity, malignancies,
and serious infections.
FDA Approves Generic Version of Valcyte
The FDA has approved Dr. Reddy’s and Endo’s AB-rated generic
versions of Roche’s Valcyte (valganciclovir) 450 mg
tablets. Valcyte is indicated for adult patients in the treatment
of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency
syndrome and prevention of CMV disease in
kidney, heart, or kidney; pancreas transplant patients at high
risk; pediatric patients in the prevention of CMV disease in kidney
or heart transplant patients at high risk.
Roche’s Valcyte is also available as an oral solution (50 mg/mL).
Hovione Files IND for Topical Minocycline
Hovione has announced that it has filed an Investigational New
Drug (IND) Application with the FDA for minocycline gel, a
novel formulation to administer topically using a new patented
crystalline base form of minocycline, one of the most widely
prescribed oral antibiotics for acne. Pending FDA’s acceptance
of the IND submission, Hovione plans to initiate human clinical
Phase 1/2 studies in early 2015.
Bristol-Myers Squibb Receives Accelerated Approval of Opdivo (nivolumab) from FDA
Bristol-Myers Squibb Company has announced that the FDA
approved Opdivo (nivolumab) injection, for intravenous
use. Opdivo is a human programmed death receptor-1 (PD-
1) blocking antibody indicated for the treatment of patients
with unresectable or metastatic melanoma and disease progression
following Yervoy (ipilimumab) and, if BRAF V600
mutation positive, a BRAF inhibitor. This indication is approved
under accelerated approval based on tumor response
rate and durability of response. Continued approval for this
