LEQSELVI delivered statistically significant
efficacy across two Phase 3 clinical trials.
At baseline, the average patient had only 13%
scalp hair coverage. At week 24, one-third of those patients
experienced 80% scalp hair coverage.
MUMBAI,
India and PRINCETON,
N.J., July 26, 2024 /PRNewswire/ -- Sun
Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP
IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its
subsidiaries or associate companies) today announced that the U.S.
Food and Drug Administration (FDA) approved LEQSELVI™
(deuruxolitinib) 8 mg tablets for the treatment of adults with
severe alopecia areata.1
Alopecia areata affects around 700,000 people in the United States, and 300,000 have severe
alopecia areata.2,3 Alopecia often leads patients to
self-treat before seeking professional help, driven by
dissatisfaction with the slow progress of existing
treatments.4,5
"LEQSELVI offers a new and effective solution that will
significantly enhance options for long-suffering patients battling
severe alopecia areata and their physicians," said Abhay Gandhi, CEO, North America Business, Sun
Pharma. "Our fast-growing dermatology business is excited to add
this novel treatment to its portfolio."
This press release features multimedia. View the full release
here:
https://www.multivu.com/players/uk/9281551-us-fda-approves-leqselvi-tm-deuruxolitinib-oral-jak-inhibitor-treatment-severe-alopecia-areata/
Alopecia areata is a common autoimmune disease in which hair
loss is thought to occur due to the collapse of immune privilege,
leading to the immune system targeting the hair follicles and
causing sudden hair loss on the scalp, face and sometimes other
areas of the body.4,5 LEQSELVI is a new, twice-daily
oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a
JAK inhibitor, LEQSELVI interrupts the pathways thought to
contribute to hair loss in severe alopecia areata.1
"We welcome the approval of LEQSELVI as a significant step for
the alopecia areata community," said Nicole
Friedland, President and CEO, National Alopecia Areata
Foundation (NAAF). "Alopecia areata is an autoimmune disease, with
significant physical, emotional and financial impacts that go
beyond hair loss. Today's announcement empowers the alopecia
community with even more choices, to which NAAF is committed, and
provides another important option for those living with severe
alopecia areata."
The approval is based on data from two multicenter, randomized,
double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1
and THRIVE-AA2, which enrolled a total of 1,220 patients with
alopecia areata who had at least 50% scalp hair loss as measured by
Severity of Alopecia Tool (SALT) for more than six months. Data
were also collected from two open-label, long-term extension trials
in which patients were eligible to enroll upon completion of the
24-week trials.
At study baseline, the average patient had only 13% of their
scalp hair coverage. In the trials, at 24 weeks, the primary
endpoint was met, with more than 30% of patients taking LEQSELVI
experiencing 80% or more scalp hair coverage (SALT
≤20).1 The number of patients taking LEQSELVI and
achieving a SALT score of ≤20 showed a consistent upward trend with
no plateau through 24 weeks.1 Additionally, up to 25% of
patients had almost all of their scalp hair back at 24 weeks (≥90%
coverage).1
"For many people with severe alopecia areata, early intervention
with effective treatment is critical," said Natasha
Mesinkovska, MD, PhD, Associate Professor and Vice Chair for
Clinical Research of Dermatology, University
of California, Irvine, and investigator in the LEQSELVI
clinical development program. "An oral JAK that delivers proven
results will be impactful for the alopecia areata community."
Across the Phase 2 dose-ranging study and Phase 3 randomized,
placebo-controlled trials, few patients (3.1%) receiving LEQSELVI 8
mg twice daily were discontinued from the trials due to adverse
reactions.1 In clinical trials, more than 100 people
continued taking deuruxolitinib for more than three
years.1
LEQSELVI may cause serious side effects including serious
infections, malignancies, thrombosis, gastrointestinal
perforations, and certain laboratory abnormalities. There also may
be an increased risk of mortality and major cardiovascular events.
LEQSELVI should not be used in patients who are CYP2C9 poor
metabolizers or who are taking moderate or strong CYP2C9
inhibitors. In placebo-controlled trials, the three most common
adverse events were headache (12.4% as compared to 9.4% with
placebo), acne (10% as compared to 4.3% with placebo), and
nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see
full Prescribing Information Including BOXED WARNING and Medication
Guide and see below for Important Safety Information.
"We are pleased with the timely approval of LEQSELVI by the U.S.
FDA," said Marek Honczarenko, MD,
PhD, Senior Vice President, Head of Development, Sun Pharma. "This
validates our team's capability to effectively bring treatments
from research and development to approval in a way that is
meaningful for physicians and patients. I want to thank all the
investigators and patients for their participation in the clinical
trials."
Sun Pharma is committed to delivering support to the alopecia
areata community and will introduce an access program to help
eligible patients get started and stay on track with their
treatment. Please visit www.LEQSELVI.com for additional
information.
About LEQSELVI™ and alopecia areata
LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective
inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment
of adult patients with severe alopecia areata. Alopecia areata is
an autoimmune disease in which the immune system attacks hair
follicles, resulting in partial or complete loss of hair on the
scalp and body. Alopecia areata may affect up to 2.5% of
the United States and global
population during their lifetime.3,6,7 The scalp is the
most commonly affected area, but any hair-bearing site can be
affected alone or together with the scalp. Onset of the disease can
occur throughout life and affects both women and men. Alopecia
areata can be associated with serious psychological consequences,
including anxiety and depression. There are currently limited
approved treatment options available for alopecia areata.
About THRIVE-AA1 and THRIVE-AA2 trial design
THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650) were
randomized, double-blind, placebo-controlled clinical trials in
1223 adult patients ages 18-65 with severe alopecia areata at sites
in the U.S., Canada and
Europe evaluating the regrowth of
scalp hair after 24 weeks of dosing using the SALT score. Patients
were randomized to receive either 8 mg twice daily or 12 mg twice
daily of deuruxolitinib or placebo for 24 weeks. The primary
endpoint was the percentage of patients achieving a SALT score of
20 or less at 24 weeks. Patients enrolled in THRIVE-AA1 and
THRIVE-AA2 were required to have at least 50 percent scalp hair
loss due to alopecia areata, as measured by SALT. A SALT score of
100 represents total scalp hair loss, whereas a score of 0
represents no scalp hair loss. The average baseline SALT score
across all patients in THRIVE-AA1 and THRIVE-AA2 was approximately
85.9 and 87.9 respectively.
Important Safety Information
Indications and Usage
LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor
indicated for the treatment of adults with severe alopecia
areata.
Limitations of Use
LEQSELVI is not recommended for use in combination with other
JAK inhibitors, biologic immunomodulators, cyclosporine or other
potent immunosuppressants.
Contraindications
LEQSELVI is contraindicated in patients who are CYP2C9 poor
metabolizers or who are using moderate or strong CYP2C9
inhibitors.
Warnings
Serious Infections
Increased risk of serious bacterial, fungal, viral and
opportunistic infections including tuberculosis (TB) that may lead
to hospitalization or death. Interrupt treatment with LEQSELVI if a
serious infection occurs until the infection is controlled. Test
for latent TB before and during therapy; treat latent TB prior to
use. Monitor all patients for active TB during treatment, even
patients with initial negative, latent TB test.
Mortality
Higher rate of all-cause mortality, including sudden
cardiovascular death with another Janus kinase inhibitor (JAK) vs.
TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not
approved for use in RA patients.
Malignancy
Malignancies have occurred in patients treated with LEQSELVI.
Higher rate of lymphomas and lung cancers with another JAK
inhibitor vs. TNF blockers in RA patients.
Major Adverse Cardiovascular Events
Higher rate of MACE (defined as cardiovascular death, myocardial
infarction, and stroke) with another Janus kinase inhibitor (JAK)
vs. TNF blockers in rheumatoid arthritis (RA) patients.
Thrombosis
Thrombosis, including PE, DVT & CVT, has occurred in
patients treated with LEQSELVI. Increased incidence of pulmonary
embolism, venous and arterial thrombosis with another JAK inhibitor
vs. TNF blockers.
Increased risk of serious adverse reactions in CYP2C9 poor
metabolizers or with concomitant use of moderate or strong CYP2C9
inhibitors
Do not treat patients who are CYP2C9 poor metabolizers or
patients taking a moderate or strong CYP2C9 inhibitor with
LEQSELVI.
Gastrointestinal Perforations
GI perforations have occurred in patients treated with LEQSELVI.
Monitor patients who may be at increased risk for gastrointestinal
perforation. Evaluate promptly patients presenting with new onset
abdominal symptoms.
Lipid elevations, anemia, neutropenia, and lymphopenia
Monitor for changes in lipids, hemoglobin, neutrophils, and
lymphocytes.
Immunizations
Avoid use of live vaccines during or immediately prior to
LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended
that patients be brought up to date with all immunizations.
Dosage
The recommended dosage of LEQSELVI for the treatment of severe
alopecia areata is 8 mg orally twice daily, with or without
food.
Before treatment with LEQSELVI, perform the following
evaluations:
- CYP2C9 genotype & use of moderate or strong CYP2C9
inhibitors;
- Active and latent tuberculosis evaluation;
- Viral hepatitis screening;
- Complete blood count (LEQSELVI treatment is not recommended in
patients with an absolute lymphocyte count (ALC) <500 cells/mm3
absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin
level <8 g/dl).
Adverse Reactions
Most common adverse reactions (≥1%) are headache, acne,
nasopharyngitis, blood creatine phosphokinase increased,
hyperlipidemia, fatigue, weight increased, lymphopenia,
thrombocytosis, anemia, skin and soft tissue infections,
neutropenia, and herpes.
Use in Specific Populations
Based on animal studies, LEQSELVI may cause fetal harm during
pregnancy. Pregnant women should be advised of a risk to the fetus.
Consider pregnancy planning and prevention for women of
reproductive potential. LEQSELVI should not be used by women who
are breastfeeding until one day after the last dose.
LEQSELVI should not be used by patients with severe renal
impairment or severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact Sun
Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
References
- LEQSELVI Prescribing Information. LEQSELVI U.S. Product
Information. July 2024. Princeton, N.J.: Sun Pharmaceutical Industries
Limited.
- National Alopecia Areata Foundation. National Alopecia
Areata Foundation.
https://www.naaf.org/.
- Benigno M. A Large Cross-Sectional Survey Study of the
Prevalence of alopecia areata in the
United States, Clinical, Cosmetic and Investigational
Dermatology 2020.
- Pratt H et al. Alopecia areata. Nat Rev Dis Primers. 2017;
3: 17011.
- King B et al. Overview of alopecia areata for managed care
and payer stakeholders in the United
States. J Manag Care Spec Pharm. 2023; 29(7):
848-856.
- Lee HH et al. Epidemiology of alopecia areata, ophiasis,
totalis, and universalis: A systematic review and meta-analysis, J
Am Acad Dermatol. 2020 Mar; 82(3): 675-682.
- Fricke et al. Epidemiology and burden of alopecia areata: a
systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8:
397-403.
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developments/circumstances after the date hereof.
About Sun Pharmaceutical Industries Limited. (CIN -
L24230GJ1993PLC019050)
Sun Pharma is the world's leading specialty generics company
with a presence in specialty, generics and consumer healthcare
products. It is the largest pharmaceutical company in India and is a leading generic company in the
U.S. as well as global emerging markets. Sun Pharma's high-growth
global specialty portfolio spans innovative products in
dermatology, ophthalmology, and onco-dermatology and accounts for
over 18% of company sales. The company's vertically integrated
operations deliver high-quality medicines, trusted by physicians
and consumers in over 100 countries. Its manufacturing facilities
are spread across six continents. Sun Pharma is proud of its
multicultural workforce drawn from over 50 nations. For further
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