Terguride Receives FDA Orphan Drug Designation For The Treatment Of Pulmonary Arterial Hypertension
Ergonex Pharma
announced that the United States Food and Drug Administration (FDA) has
granted orphan drug designation to Terguride for the treatment of pulmonary
arterial hypertension (PAH). Terguride is currently being evaluated for PAH
in a pivotal Phase II trial in Europe.
"The FDA’s grant of orphan drug designation to Terguride for PAH
encourages and strengthens our development program by offering regulatory,
clinical development and commercial benefits," said Dr Rudolf Reiter, CEO
of Ergonex Pharma. "We believe that Terguride can provide a significant
therapeutic benefit in PAH by inhibiting excess serotonin signalling."
The U.S. Orphan Drug Act is intended to assist and encourage companies
to develop safe and effective therapies for the treatment of rare diseases,
which affect 200.000 persons or less in the United States. Under the Orphan
Drug Act, upon marketing authorization, the FDA does not accept or approve
other applications to market the same medicinal product for the same
indication for a seven-year period. In addition to potential market
exclusivity, orphan drug designation provides protocol assistance, advice
on the conduct of clinical trials, tax credits for clinical research
expenses, grant funding for research of rare disease treatments and waiver
of the Buy diflucan pills Prescription Drug User Fee Act filing fee.
About Terguride
Terguride has strong anti-serotoninergic activity by acting as a potent
antagonist on 5-HT2B and 5-HT2A receptors: It has anti-proliferative and
anti-fibrotic activity and drives reverse remodelling processes. Serotonin
is a signal molecule in the body with many functions. In the blood vessel
walls of the lung it stimulates proliferation of smooth muscle cells and
narrowing of the blood vessels, which leads to PAH. Excessive proliferative
effects of serotonin on the heart contribute directly to progression
towards heart failure.
Terguride is clinically approved in Japan for hyperprolactinemia acting
as partial dopamine agonist on the pituitary.
About Pulmonary arterial hypertension
Pulmonary arterial hypertension is a disorder of the blood vessels in
the lung, in which the pressure in large blood vessel rises above normal.
Walls of the blood vessels are thickened and hardened, becoming less
elastic and decrease in lumen leading to increases the pressure. Patients
with PAH suffer from extreme shortness of breath as the heart struggles to
pump against these high pressures causing such patients to ultimately die
of heart failure. PAH can occur with no known underlying cause, or it can
occur secondary to diseases such as connective tissue disease, congenital
heart defects, cirrhosis of the liver and HIV infection.
About Ergonex Pharma
Ergonex Pharma is a pharmaceutical company focussed on developing and
commercialising well-tolerated and effective products for novel and
typically underserved indications. This is being achieved by forging
collaborations with commercial and academic partners with expertise in the
field of interest and through outsourcing activities to service providers.
(For further information see )
Ergonex Pharma GmbH
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