United Therapeutics Corporation
) surged 27.5% in the past one week after the U.S. Food and Drug
Administration (FDA) approved the oral use of Remodulin
The oral formulation has been approved under the brand name -
Orenitram for the treatment of pulmonary arterial hypertension
(PAH) patients (in WHO Group I) to improve exercise capacity. We
note that Remodulin is already approved for both subcutaneous
(SC) and intravenous (IV) use.
The news comes as a relief for United Therapeutics as the FDA
had previously issued two complete response letters (CRLs) to the
company's new drug application (NDA) for Orenitram and a final
decision was expected by Feb 16, 2014.
The first CRL was issued in Oct 2012. In Jan 2013, United
Therapeutics resubmitted its NDA to address the concerns raised
in FDA's CRL. However, the company suffered a setback when the
FDA issued a second CRL in Mar 2013.
At the time of issuing the first CRL, the FDA had raised
questions about the clinical importance of the 6 Minute Walk
Distance (6MWD) effect size shown in the FREEDOM-M study, the
lack of improvement in time to clinical worsening in all three
phase III studies conducted with Orenitram, and the failure to
show a statistically significant effect on 6MWD in the two
Thereafter, United Therapeutics conducted an end of review
meeting with the FDA in early May 2013 to discuss the second CRL.
At that meeting, additional analyses and contextual information
about combination studies in the field were presented.
United Therapeutics resubmitted its NDA, which was accepted by
the FDA in Sep 2013. Hence, the approval comes as a major relief
for United Therapeutics after suffering two setbacks.
However, United Therapeutics is facing a patent challenge for
) generic unit, Sandoz, is seeking approval for its generic
version of Remodulin (10 mg/mL). United Therapeutics has filed a
patent infringement lawsuit against Sandoz.
United Therapeutics currently carries a Zacks Rank #3 (Hold).
Better-ranked stocks include
). Both carry a Zacks Rank #1 (Strong Buy).
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