Biofrontera submits application for FDA approval of new BF-RhodoLED® XL lamp
March 31 2021 - 3:40AM
Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the
“Company”), an international biopharmaceutical company, today
announced the submission for approval of a new, significantly
larger red-light source for photodynamic therapy (PDT) to be used
in combination with Ameluz®, the BF-RhodoLED® XL, to the U.S. Food
and Drug Administration (FDA).
The new BF-RhodoLED® XL is to be approved in
combination with Ameluz® for the treatment of mild and moderate
actinic keratoses on the face and scalp. This corresponds to the
current approval of Ameluz®, with plans to broaden the label to
include additional indications in the future. The new PDT lamp
enables the treatment of larger areas as well as the simultaneous
exposure of several actinic keratoses distant from each other. This
regulatory filing is independent of the change in product
information submitted to the FDA in February to allow the use of up
to three tubes of Ameluz® per treatment, but complements it in an
effort to treat larger areas. Currently, the product information
and thus reimbursement is limited to the use of one tube of Ameluz®
per treatment.
Ahead of the submission to the FDA, the new lamp
was protected by several patent applications, which, due to the
specifics of the FDA's combination approval, will also protect
Ameluz® itself in the US, our key market, once the patents are
granted.
"The new BF-RhodoLED® XL offers an improved
control panel with a significantly enhanced graphical user
interface and intuitive user navigation. The lamp’s extremely
versatile setting options allow the treatment to be specifically
adapted to the needs of each individual patient," explains Prof.
Dr. Lübbert, CEO of Biofrontera AG. "Combined with a modern,
high-quality design, we expect strong customer acceptance
particularly in the U.S. and, as a result, an increase in Ameluz®
sales."
The treatment parameters of the new BF-RhodoLED®
XL, such as light dose, illumination time and wavelength of light
are identical to the current model BF-RhodoLED®. The approval, as
with the BF-RhodoLED®, will be granted as a combination approval
with our prescription drug Ameluz®, in accordance with FDA
requirements. In order to meet the FDA's strict requirements for
the manufacture of a class III medical device, production of the
new lamp has, similar to the older model, been established at the
Company's headquarters in Leverkusen. At present, there are no
plans to market the new BF-RhodoLED® XL in Europe. The current
BF-RhodoLED® model will continue to be offered in all our
markets.
-End-
Biofrontera AGPamela Keck, Head of Investor
Relationsir@biofrontera.com+49-214-87632-0
About Biofrontera:
Biofrontera AG is a biopharmaceutical company
specializing in the development and sale of dermatological drugs
and medical cosmetics.
The Germany-based company, with over 150
employees worldwide, develops and markets innovative products for
the care, protection and treatment of the skin. The company’s lead
product is the combination of Ameluz®, a topical prescription drug,
and medical device BF-RhodoLED® for the photodynamic therapy of
certain superficial skin cancers and their precursors. Ameluz® has
been marketed in the EU since 2012 and in the United States since
May 2016. In addition, the company markets the prescription
medication Xepi® for the treatment of impetigo in the United
States. In the EU, the company also sells the dermocosmetics series
Belixos®, which offers specialized care for damaged or diseased
skin.
Biofrontera is the first German founder-led
pharmaceutical company to receive a centralized European and a US
approval for a drug developed in-house. The Biofrontera Group was
founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is
listed on the Frankfurt Stock Exchange (Prime Standard) and on the
US NASDAQ.www.biofrontera.com.
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