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
Company’s Marketing Authorization Application (MAA) to the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human
Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as
B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB)
has been validated and is now under CHMP review. A CHMP opinion is
anticipated in the second half of 2024.
“The validation of our MAA for review by CHMP is an important
step toward our goal to bring VYJUVEK to patients in the EU who are
living with DEB,” said Suma Krishnan, President, Research &
Development, Krystal Biotech, Inc. “We look forward to working
closely with EMA through the MAA review process, as VYJUVEK has the
potential to fulfil an unmet medical need for DEB patients and
their families.”
In September 2023, Krystal Biotech received a positive opinion
from the EMA Pediatric Committee on the Pediatric Investigation
Plan for VYJUVEK for the treatment of DEB. Based on this positive
opinion, the Company would be eligible for up to an additional two
years of marketing exclusivity in the EU, on top of the ten-year EU
market exclusivity after market approval in the EU. Previously,
VYJUVEK received Orphan Drug Designation and PRIority Medicines
(PRIME) eligibility from the EMA.
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.
IndicationVYJUVEK 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 only 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 Twitter.
Forward-Looking StatementsAny statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., including statements about the
timing of a potential CHMP opinion anticipated in the second half
of 2024 for VYJUVEK and prospects regarding the timing of the
approval and the commercial availability of VYJUVEK in Europe 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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