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 25,
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."
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 CYP2CP 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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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
information, please visit www.sunpharma.com and follow us on
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