-- PRESS RELEASE: 3M Files sNDA For Aldara Cream 5% >MMM --
ST. PAUL, Minn.--(BUSINESS WIRE)--June 11, 2003--
- First Immune Response Modifier to Seek Indication to Treat
Common Non-Melanoma Skin Cancer -
3M announced today that the company has submitted a supplemental new drug
application (sNDA) with the U.S. Food and Drug Administration to market Aldara
(imiquimod) Cream, 5%, an immune response modifier (IRM), for the treatment of
superficial basal cell carcinoma (sBCC), a common form of non-melanoma skin
cancer. Approximately 1.3 million new cases of non-melanoma skin cancer occur in
the United States each year. Of these, almost 1 million are basal cell
carcinomas (BCCs). Aldara cream, currently the leading prescription treatment
for external genital and perianal warts, is the first IRM application submitted
for the sBCC indication. Additionally, 3M submitted a sNDA last month for Aldara
cream for the treatment of actinic keratosis, a common precursor to skin cancer.
"This submission is a significant milestone in our efforts to bring Aldara
cream to market for sBCC," said Barry Labinger, division vice president,
Pharmaceuticals Division. "Aldara cream will represent an important new option
for dermatologists and other physicians who are treating patients with this
common form of non-melanoma skin cancer," he concluded. Labinger confirmed that
3M remains on track to receive an anticipated marketing approval in mid-2004 for
this indication. 3M continues to build a pipeline for new IRM molecules for a
broad range of indications.
The Aldara cream sNDA is based on positive results from two double-blind,
randomized, placebo-controlled clinical trials involving 724 patients with
sBCCs, confirmed by biopsy. Patients were treated with Aldara cream or placebo
once daily, five or seven times per week, for six weeks. The clinical studies
showed the optimal dosing to be five times per week, with a histological
clearance rate of 82 percent in patients treated with Aldara cream compared to
only 3 percent in the placebo group. Patients treated with Aldara cream seven
times per week showed a histological clearance rate of 79 percent compared to 3
percent in the placebo group.
In these clinical studies, the most frequently reported adverse reactions were
local skin and application site reactions, including flaking/scaling,
induration, edema, erythema, scabbing/crusting and ulceration. These reactions
were generally mild to moderate ranging to severe in nature.
BCC is the most common form of non-melanoma cancer worldwide. In the vast
majority of cases, it is thought to be caused by exposure to the harmful
ultraviolet rays of the sun. According to the American Cancer Society, 35
percent to 50 percent of people diagnosed with one BCC will develop a new skin
cancer within five years of the first diagnosis. Common treatments for BCC
include excisional surgery, cryosurgery, MOHS micrographic surgery, curettage
and electrodesiccation.
3M Pharmaceuticals launched Aldara cream in 1997 for the treatment of external
genital and perianal warts. Aldara cream is 3M
Gerelateerde artikelen
- Aldara zalf - Imiquimod zorgt voor verdwijning van huidkankertumoren, aldus gerandomiseerde dubbelblinde fase II studie.
- Zalven: Aldara - Imiquimod krijgt toestemming om als medicijn tegen niet-melanome huidkankers te worden gebruikt na positieve resultaten uit twee gerandomiseerde dubbelblinde studies
- Zalven: Aldara zalf - Imiquimod
Plaats een reactie ...
Reageer op "Zalven: Aldara - Imiquimod krijgt toestemming om als medicijn tegen niet-melanome huidkankers te worden gebruikt na positieve resultaten uit twee gerandomiseerde dubbelblinde studies"