Pint Pharma Announces the Approval of ORLADEYO® (berotralstat), the First Oral Therapy Indicated for Preventing Hereditary Angioedema (HAE) Attacks in Adult and Pediatric Patients Aged 12 and Older in Mexico
13 Mayo 2024 - 5:23PM
Business Wire
It is with great pleasure that we announce the Federal
Commission for Protection against Health Risks (COFEPRIS) in Mexico
has granted approval for oral, once-daily ORLADEYO® (berotralstat)
for the prophylaxis of hereditary angioedema (HAE) attacks in
adults and pediatric patients 12 years of age or older.
Hereditary angioedema is a genetic disorder that causes
recurrent episodes of sudden and painful swelling of the skin,
mucous membranes and submucosal tissues. Until recently, treatment
options for HAE were limited, and patients faced the constant risk
of severe attacks and compromised quality of life.
"The approval of Orladeyo by COFEPRIS is excellent news for the
hereditary angioedema patient community in Mexico," comments Dr.
Valnei Canutti, Chief Scientific Officer at Pint Pharma. "This
innovative ORAL therapy represents a breakthrough for those living
with this rare condition, offering an effective and convenient
long-term prophylaxis option, preventing hereditary angioedema
attacks."
According to David Munoz, CEO of Pint Pharma, "In addition to
providing direct benefits to patients, the availability of Orladeyo
in Mexico highlights our continued commitment to advancing research
and innovation in the field of rare disease healthcare."
"The approval of Orladeyo is a great achievement for patients,
and proof of the successful collaboration between the medical
community, regulators, and pharmaceutical companies in Mexico to
provide new treatment options," expressed Mauricio Botero, General
Manager of Pint Pharma in LatAm North Cluster.
About Orladeyo
ORLADEYO® (berotralstat) is the first and only oral therapy
specifically designed to prevent hereditary angioedema (HAE)
attacks in adult and pediatric patients aged 12 and older. One
ORLADEYO capsule per day prevents HAE attacks by reducing plasma
kallikrein activity. ORLADEYO is a product of BioCryst
Pharmaceuticals, Inc., and its registration, commercialization and
distribution are exclusively handled by Pint Pharma in Latin
America.
About Pint Pharma
Pint Pharma, headquartered in Vienna, Austria, is a specialty
pharmaceutical company focused on acquiring or licensing, and
commercializing pharmaceutical products for Latin America. We are a
community-centered company and pride ourselves on providing
exceptional expertise and know-how from the Latin American
pharmaceutical industry, striving to deliver the best treatment and
service to the population through strategic alliances with our
global business partners.
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version on businesswire.com: https://www.businesswire.com/news/home/20240513238668/en/
Jorge Camacho Chief of Strategy and Portfolio Strategy email:
Jorge.camacho@pint-pharma.com
Valnei Canutti Chief Scientific Officer email:
valnei.canutti@pint-pharma.com