Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the company`s application for Orfadin oral suspension has been submitted to the US Food and Drug Administration (FDA). This new dosage form has been developed to facilitate the ease and accuracy of administration for Orfadin in paediatric patients as well as to increase convenience for patients and their caregivers.
Orfadin is used for the treatment of hereditary tyrosinemia type 1 (HT-1), a rare genetic disorder which can cause liver failure, kidney dysfunction and neurological problems.
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 inflammation and genetic diseases, with three late stage biological development projects within haemophilia and neonatology. We also market a portfolio of specialty and rare disease products for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2012, Sobi had total revenues of SEK 1.9 billion (€ 215 M) and about 500 employees. The share (SOBI.ST) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE