PMID- 12090728
OWN - NLM
STAT- MEDLINE
DCOM- 20030114
LR  - 20171116
IS  - 1472-4472 (Print)
IS  - 1472-4472 (Linking)
VI  - 3
IP  - 4
DP  - 2002 Apr
TI  - Treprostinil sodium Pharmacia.
PG  - 582-6
AB  - United Therapeutics Corp (UTC) is developing treprostinil sodium (Remodulin, 
      UT-15), a stable structural analog of prostacyclin, for the potential treatment 
      of primary pulmonary (arterial) hypertension (PAH), peripheral vascular disease 
      (PVD) and other cardiovascular conditions [327593], including critical limb 
      ischemia (CLI) [412483]. In August 2000, UTC submitted the initial, non-clinical 
      sections of an NDA for the treatment of pulmonary hypertension [378906]. 
      Treprostinil, which had previously been designated as an Orphan Drug, was also 
      awarded Priority Review status by the US FDA in October 2000 [385864], [386271]. 
      In December 2000, UTC agreed with the FDA that the NDA for treprostinil did not 
      need to be presented to the Cardiovascular and Renal Drugs Advisory Committee, 
      which was expected to allow UTC and the FDA to work towards the 6-month Priority 
      Review timeline [393888]. On August 9, 2001, the advisory committee recommended 
      approval of treprostinil and UTC refiled the NDA on the same day [418682]. In 
      February 2002, the FDA issued an approvable letter for treprostinil injection for 
      the treatment of PAH. The FDA proposed drug labeling for PAH consistent with the 
      treatment of both primary and secondary pulmonary hypertension in patients with 
      New York Heart Association (NYHA) Class II-IV symptoms. The approvable letter 
      also stated that the FDA intended to approve treprostinil with a requirement that 
      UTC subsequently conduct a post-marketing controlled clinical trial to verify and 
      further describe the drug's clinical benefit [439278]. In February 2001, UTC 
      submitted a marketing authorization application (MAA) in France for approval of 
      treprostinil for the treatment of PAH. Upon approval of the MAA, UTC planned to 
      file for Mutual Recognition in other European countries and was also preparing 
      similar submissions to non-European countries [391986], [397958]. By early 2001, 
      phase II trials of treprostinil for the treatment of CLI were underway [412483]. 
      In March 2001, the company was planning a phase III pivotal study in late-stage 
      PVD by the end of 2001 [424180]. In April 2000, UTC was issued US-06054486 for 
      the method of treating PVD with treprostinil [364130]. In February 2000, UTC 
      entered into an agreement with Paladin Labs for the exclusive Canadian 
      distribution of treprostinil for the remainder of clinical trials and after 
      regulatory approvals [357302]. In November 2000, UTC and Antigen Pharmaceuticals 
      entered into a strategic alliance for the distribution of treprostinil in the UK 
      and Ireland [390157]. In November 2000, Deutsche Banc Alex Brown predicted a 
      sales potential of US $250 million to US $350 million [418736]. In August 2001, 
      Merril Lynch predicted sales of US $10 million to $20 million in 2002 [420652].
FAU - Chattaraj, Sarat C
AU  - Chattaraj SC
AD  - Mylan Pharmaceuticals Inc, Morgantown, WV 26504-4310, USA. sarat_c82@hotmail.com
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Curr Opin Investig Drugs
JT  - Current opinion in investigational drugs (London, England : 2000)
JID - 100965718
RN  - 0 (Cardiovascular Agents)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - DCR9Z582X0 (Epoprostenol)
RN  - RUM6K67ESG (treprostinil)
SB  - IM
MH  - Cardiovascular Agents/adverse effects/pharmacokinetics/*pharmacology
MH  - Clinical Trials as Topic
MH  - Epoprostenol/adverse effects/*analogs & 
      derivatives/pharmacokinetics/*pharmacology
MH  - Extremities/blood supply
MH  - Humans
MH  - Hypertension, Pulmonary/drug therapy
MH  - Ischemia/drug therapy
MH  - Peripheral Vascular Diseases/drug therapy
MH  - Platelet Aggregation Inhibitors/adverse effects/pharmacokinetics/*pharmacology
RF  - 40
EDAT- 2002/07/02 10:00
MHDA- 2003/01/15 04:00
CRDT- 2002/07/02 10:00
PHST- 2002/07/02 10:00 [pubmed]
PHST- 2003/01/15 04:00 [medline]
PHST- 2002/07/02 10:00 [entrez]
PST - ppublish
SO  - Curr Opin Investig Drugs. 2002 Apr;3(4):582-6.