United Kingdom’s MHRA Approves YORVIPATH® (palopegteriparatide) in Great Britain for the Treatment of Adults with Chronic Hypoparathyroidism
24 Abril 2024 - 7:30AM
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United
Kingdom’s Medicines & Healthcare products Regulatory Agency
(MHRA) has granted marketing authorization for YORVIPATH®
(palopegteriparatide; developed as TransCon™ PTH) in Great Britain
as a parathyroid hormone (PTH) replacement therapy indicated for
the treatment of adults with chronic hypoparathyroidism, and has
also granted YORVIPATH orphan drug status. YORVIPATH is a prodrug
of parathyroid hormone (PTH 1-34) administered once daily.
“With today’s MHRA approval of YORVIPATH, we are expanding our
global geographic reach to meet the needs of adults with chronic
hypoparathyroidism in Great Britain,” said Camilla Harder Harvig,
Executive Vice President and Chief Commercial Officer at Ascendis
Pharma.
MHRA approval of YORVIPATH is based on the same dossier
submitted with Ascendis Pharma’s Marketing Authorisation
Application to the European Medicines Agency, which led to European
Commission authorization of YORVIPATH in the European Union in
November 2023. Orphan status provides 10 years of market
exclusivity in Great Britain with respect to similar medicinal
products in the approved orphan indication of chronic adult
hypoparathyroidism. TransCon PTH is also in development for the
treatment of adults with chronic hypoparathyroidism in the
United States, Japan, and other countries.
About HypoparathyroidismHypoparathyroidism is
an endocrine disease caused by insufficient levels of PTH, the
primary regulator of calcium and phosphate balance in the body,
acting directly on bone and kidneys and indirectly on the
intestine. Hypoparathyroidism is considered chronic if it persists
>6 months following surgery per the 2016 Endocrine Society
Guidelines, 2019 Canadian and International Consensus Statement,
and 2022 European Society of Endocrinology Consensus
Statement. Individuals with hypoparathyroidism may experience a
range of severe and potentially life-threatening short-term and
long-term complications, including neuromuscular irritability,
renal complications, extra-skeletal calcifications, and cognitive
impairment. Post-surgical hypoparathyroidism accounts for the
majority of cases (70-80%), while other etiologies include
autoimmune, genetic, and idiopathic causes.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform to build a
leading, fully integrated biopharma company focused on making a
meaningful difference in patients’ lives. Guided by its core values
of Patients, Science, and Passion, Ascendis uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Europe and the United States. Please visit
ascendispharma.com to learn more.
Forward-Looking Statements This press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, included in this press release regarding
Ascendis’ future operations, plans and objectives of management are
forward-looking statements. Examples of such statements include,
but are not limited to, statements relating to (i) Ascendis’
ability to meet the needs of adults with chronic hypoparathyroidism
in Great Britain, (ii) Ascendis’ ability to apply its innovative
platform technology to build a leading, fully integrated biopharma
company and (iii) Ascendis’ use of its TransCon technologies to
create new and potentially best-in-class therapies. Ascendis may
not actually achieve the plans, carry out the intentions or meet
the expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions, expectations and projections
disclosed in the forward-looking statements. Various important
factors could cause actual results or events to differ materially
from the forward-looking statements that Ascendis makes, including
the following: dependence on third party manufacturers,
distributors and service providers for Ascendis’ products and
product candidates; unforeseen safety or efficacy results in
Ascendis’ development programs or on-market products; unforeseen
expenses related to commercialization of any approved Ascendis
products; unforeseen expenses related to Ascendis’ development
programs; unforeseen selling, general and administrative expenses,
other research and development expenses and Ascendis’ business
generally; delays in the development of its programs related to
manufacturing, regulatory requirements, speed of patient
recruitment or other unforeseen delays; Ascendis’ ability to obtain
additional funding, if needed, to support its business activities;
the impact of international economic, political, legal, compliance,
social and business factors. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to Ascendis’ business in general, see Ascendis’
Annual Report on Form 20-F filed with the U.S. Securities and
Exchange Commission (SEC) on February 7, 2024 and
Ascendis’ other future reports filed with, or submitted to,
the SEC. Forward-looking statements do not reflect the
potential impact of any future licensing, collaborations,
acquisitions, mergers, dispositions, joint ventures, or investments
that Ascendis may enter into or make. Ascendis does not assume any
obligation to update any forward-looking statements, except as
required by law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company
logo, TransCon, and YORVIPATH® are trademarks owned by the Ascendis
Pharma group. © April 2024 Ascendis Pharma A/S.
Investor Contacts: |
Media Contact: |
Tim Lee |
Melinda Baker |
Ascendis Pharma |
Ascendis Pharma |
+1 (650) 374-6343 |
+1 (650) 709-8875 |
tle@ascendispharma.com |
media@ascendispharma.com |
ir@ascendispharma.com |
|
|
|
Patti Bank |
|
ICR Westwicke |
|
+1 (415) 513-1284 |
|
patti.bank@westwicke.com |
|
Ascendis Pharma AS (NASDAQ:ASND)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Ascendis Pharma AS (NASDAQ:ASND)
Gráfica de Acción Histórica
De May 2023 a May 2024