Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a
commercial-stage biotechnology company focused on the discovery,
development and commercialization of genetic medicines to treat
diseases with high unmet medical needs, today announced that the
U.S. Centers for Medicare & Medicaid Services (CMS) has
assigned a permanent and product-specific J-code (J3401) for
VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and
Drug Administration-approved treatment for dystrophic epidermolysis
bullosa (DEB). The J-code for VYJUVEK became effective on January
1, 2024.
“The permanent J-code will help ensure efficient and accurate
reimbursement of VYJUVEK and further enable us to bring this
important treatment to DEB patients in need,” said Krish S.
Krishnan, Chairman & CEO at Krystal Biotech.
J-codes are permanent reimbursement codes used by government
payers and commercial insurers to facilitate billing of treatments
that must be administered by a healthcare professional. J-codes
simplify and streamline the billing and reimbursement processes,
allowing for efficient claims processing.
The permanent J-code for VYJUVEK has been published by CMS
and is available here.
About Dystrophic Epidermolysis Bullosa (DEB)DEB
is a rare and severe disease that affects the skin and mucosal
tissues. It is caused by one or more mutations in a gene
called COL7A1, which is responsible for the production of the
protein type VII collagen (COL7) that forms anchoring fibrils that
bind the dermis (inner layer of the skin) to the epidermis (outer
layer of the skin). The lack of functional anchoring fibrils in DEB
patients leads to extremely fragile skin that blisters and tears
from minor friction or trauma. DEB patients suffer from open
wounds, which leads to skin infections, fibrosis which can cause
fusion of fingers and toes, and ultimately an increased risk of
developing an aggressive form of squamous cell carcinoma which, in
severe cases, can be fatal.
About VYJUVEKVYJUVEK is a non-invasive,
topical, redosable gene therapy designed to deliver two copies of
the COL7A1 gene when applied directly to DEB wounds.
VYJUVEK was designed to treat DEB at the molecular level by
providing the patient’s skin cells the template to make normal COL7
protein, thereby addressing the fundamental disease-causing
mechanism.
Indication
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based
gene therapy indicated for the treatment of wounds in patients six
months of age and older with dystrophic epidermolysis bullosa with
mutation(s) in the collagen type VII alpha 1 chain
(COL7A1) gene.
IMPORTANT SAFETY INFORMATION
Adverse ReactionsThe most common adverse drug
reactions (incidence >5%) were itching, chills, redness, rash,
cough, and runny nose. These are not all the possible side
effects with VYJUVEK. Call your healthcare provider for medical
advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Krystal
Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088
or http://www.fda.gov/medwatch.
ContraindicationsNone.
Warnings and PrecautionsVYJUVEK gel must be
applied by a healthcare provider.
After treatment, patients and caregivers should be careful not
to touch treated wounds and dressings for 24 hours.
Wash hands and wear protective gloves when changing wound
dressings. Disinfect bandages from the first dressing change with a
virucidal agent, and dispose of the disinfected bandages in a
separate sealed plastic bag in household waste. Dispose of the
subsequent used dressings in a sealed plastic bag in household
waste.
Patients should avoid touching or scratching wound sites or
wound dressings.
In the event of an accidental exposure flush with clean water
for at least 15 minutes.
For more information, see full U.S. Prescribing
Information.
About Krystal Biotech, Inc.Krystal Biotech,
Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company
focused on the discovery, development and commercialization of
genetic medicines to treat diseases with high unmet medical needs.
VYJUVEK® is the Company’s first commercial product, the first-ever
redosable gene therapy, and the first medicine approved by the FDA
for the treatment of dystrophic epidermolysis bullosa. The Company
is rapidly advancing a robust preclinical and clinical pipeline of
investigational genetic medicines in respiratory, oncology,
dermatology, ophthalmology, and aesthetics. Krystal Biotech is
headquartered in Pittsburgh, Pennsylvania. For more information,
please visit http://www.krystalbio.com, and follow @KrystalBiotech
on LinkedIn and X (formerly Twitter).
Forward-Looking Statements Any statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., including statements about the
permanent J-code, reimbursement of VYJUVEK, and the Company
bringing VYJUVEK to DEB patients in need, and other statements
containing the words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “target,”
“potential,” “likely,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: uncertainties associated with
regulatory review of clinical trials and applications for marketing
approvals, the availability or commercial potential of product
candidates, the sufficiency of cash resources and need for
additional financing and such other important factors as are set
forth under the caption “Risk Factors” in the Company’s annual and
quarterly reports on file with the U.S. Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent the Company’s views as of
the date of this release. The Company anticipates that subsequent
events and developments will cause its views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, it specifically disclaims
any obligation to do so. These forward-looking statements should
not be relied upon as representing the Company’s views as of any
date subsequent to the date of this release.
CONTACTInvestors and Media:Meg
DodgeKrystal Biotech, Inc.mdodge@krystalbio.com
Krystal Biotech (NASDAQ:KRYS)
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