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Swedish Orphan Biovitrum AB (publ): FDA validates Orfadin® oral suspension filing

Sobi (Swedish Orphan Biovitrum AB (publ)) today announced that the Food and
Drug Administration (FDA) has initiated review of the oral suspension
formulation of Orfadin (nitisinone) for the treatment of Hereditary
Tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease characterised by
signs and symptoms that begin in the first few months of life. In affected
infants the disease may result in liver and kidney failure, and can be fatal
if not diagnosed and treated early in life.

The dossier was submitted to FDA in June and a formal decision is expected
during the second quarter 2016. The oral suspension of Orfadin, if approved,
will facilitate dosing accuracy and will simplify ease of use by reducing the
number of steps required to administer the medicine.

"The oral suspension formulation is a demonstration of Sobi's commitment to
the needs of the infants and children diagnosed with HT-1 early in life. As
new-born screening for HT-1 is becoming more widespread the need for such
formulations is evident," says Michael Yeh, Vice President Head of Medical
for Sobi in North America. "We are pleased about the FDA validation of the
filing of the Orfadin oral suspension, and believe that the oral suspension
will contribute to address an unmet need and improve the treatment
opportunities of paediatric patients with HT-1."

Orfadin is the only FDA approved therapy for use as an adjunct to dietary
restriction of tyrosine and phenylalanine for the treatment of hereditary
tyrosinaemia type 1 (HT-1). It is also approved in the EU and several other
countries and the European Commission recently approved the oral suspension
formulation of Orfadin.


About Orfadin

Orfadin (nitisinone) blocks the breakdown of tyrosine, thereby reducing the
amount of toxic by-products in the body. People with Hereditary Tyrosinaemia
type-1 (HT-1) have problems breaking down an amino acid called tyrosine.
Toxic by-products are formed and accumulate in the body, which can cause
liver failure, renal dysfunction and neurological complications. In the most
common form of the disease, symptoms arise within the first six months of the
child's life. Patients must maintain a special diet in combination with
Orfadin treatment as tyrosine remains in the body. Approximately 1,000
persons are identified as living with HT-1 today. Orfadin is a proprietary
product and is developed by and marketed globally by Sobi.

About Sobi

Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on Haemophilia, Inflammation and Genetic diseases. We also market a
portfolio of specialty and rare disease products for partner companies across
Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion
(USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on
NASDAQ OMX Stockholm. More information is available

For more information please contact

| Media relations Investor relations |
| Oskar Bosson, Head of Communications Jörgen Winroth, Vice President, Head of Investor Relations |
| T: +46 70 410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135 |
| |
033e_FDA validation_Orfadin Oral Suspension


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Globenewswire


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