Orfadin® Oral Suspension approved in the US
(Thomson Reuters ONE) -
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) announced today that the US Food
and Drug Administration (FDA) has as of 22 April 2016, approved Orfadin®
(nitisinone) Oral Suspension for the treatment of hereditary tyrosinaemia type-
1 (HT-1) in combination with dietary restriction of tyrosine and phenylanine.
HT-1 is a rare genetic disease that affects infants and children. It is
progressive and may result in liver and kidney complications and can be fatal if
untreated.
Twenty years ago, before pharmacological treatment was available, fewer than one
third of infants diagnosed with HT-1 before two months of age lived past their
second birthday.[1] Today, treatment with Orfadin as an adjunct to dietary
restriction as well as early diagnosis have improved outcomes for HT-1
patients.[2] Orfadin is approved in the US and several other countries for the
treatment of patients with HT-1 in combination with dietary restriction of
tyrosine and phenylalanine.
"The HT-1 patient journey - from early screening and diagnosis, to improved
medical care associated with continuous higher survival rates - has driven
Sobi's commitment to develop new strengths and formulations for Orfadin to
continually meet the medical needs of HT-1 patients", says Michael Yeh, Vice
President Medical Affairs.
Maintaining a strong patient-centric approach is central, and Sobi is
continuously developing initiatives based on the expressed needs of patients,
healthcare providers and healthcare professionals. As more countries introduce
new-born screening for HT-1, infants are diagnosed earlier in life. Dosing is
adjusted by weight and as babies grow month by month, their dose is adjusted
continuously. The new oral suspension of Orfadin aims to facilitate
administration, especially in paediatric use.
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About Orfadin®
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, renal and neurological complications. Orfadin®
(nitisinone) blocks the breakdown of tyrosine, thereby reducing the amount of
toxic by-products in the body. 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 is not adequately
broken down. 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. For full US prescribing information, please see
www.orfadin.com.
About Sobi(TM)
Sobi(TM) 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 speciality and rare disease products across Europe, the Middle
East, North Africa and Russia for partner companies. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and approximately 700 employees. The share (STO:SOBI) is listed on
NASDAQ Stockholm. More information is available on www.sobi.com.
For more information please contact
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
Communications Relations
+46 70 410 71 80 +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
oskar.bosson(at)sobi.com jorgen.winroth(at)sobi.com
--------------------------------------------------------------------------------
[1] van Spronsen FJ, Thomasse Y, Smit GP, et al. Hepatology.
1994;20(5):1187-1191
[2] Orfadin EPAR: Product information 25/07/2013 Orfadin -EMEA/H/C/000555
-IB/0045
020e_Orfadin oral supsension approval US:
http://hugin.info/134557/R/2006670/741509.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via GlobeNewswire
[HUG#2006670]
Unternehmensinformation / Kurzprofil:
Datum: 26.04.2016 - 08:00 Uhr
Sprache: Deutsch
News-ID 466348
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