Increased shelf life and extended out-of-refrigeration for Sobi’s Orafidin

Swedish Orphan Biovitrum AB known as Sobi said Tuesday that the FDA has approved increased shelf life and extended out-of-refrigeration for Orfadin capsules.

Orafidin is a treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine, and can now be shelfed for 36 months, a year longer than according to the previous approval.

The new temperature limit has been approved for all strengths of Orfadin, which are 2 mg, 5 mg, 10 mg and 20 mg, while the out-of-refrigeration approval is for 20 mg strenght.

“The approval for increased shelf life and extended out-of-refrigeration time may help make Orfadin an even more flexible treatment option,” says Jon Miller, President of the Network of Tyrosinemia Advocates (NOTA). “Continued treatment improvements like this may help to lessen the burden of HT-1 for patients and their families.”