Tracleer and PPH News New PH Therapy Gets FDA Nod
by John C. Martin
02-03-05 - A medication for people with advanced forms of pulmonary arterial hypertension (PH) has been granted approval by the Food and Drug Administration. Iloprost, to be marketed as Ventavis®, is designed as an inhaled solution for people classified as having stage III or IV pulmonary hypertension. The announcement was made by CoTherix, a pharmaceutical firm based in northern California that will be heading up marketing efforts for the drug. "This approval provides PAH patients with a non-invasive treatment option that avoids the complications associated with intravenous or subcutaneous (delivered in a syringe) prostacyclin delivery," said Donald Santel, CoTherix's CEO, in a statement. 'A New Option'
Two current therapies for PH, Flolan (a synthetic prostacyclin) and Remodulin (a prostacyclin analog), are delivered either through a surgically-placed catheter that delivers the medication through a continuous infusion, or by continuous subcutaneous (through a syringe) or IV administration.1 Ventavis is an inhaled form of iloprost, a prostacyclin analog designed to widen abnormally narrowed blood vessels. The drug is also aimed at improving blood circulation and exercise capacity in PH patients. "We are excited that, with the approval of Ventavis, physicians have a new option for treatment," said Rino Aldrighetti, president of the Pulmonary Hypertension Association. "Hope for patients with this difficult and often misdiagnosed illness is growing." Supportive Study Data
The FDA approval was based on a randomized, double-blind, placebo-controlled clinical trial involving more than 200 people with advanced pulmonary hypertension. Half had unknown causes for the disease, and the rest of the cases were associated with connective tissue disease (including CREST and scleroderma), anorexigen use, or chronic thromboembolic disease. Doctors in the study were looking for improvements in the severity of the disease, increases in walking distance of at least 10% in a 6-minute test, and disease stability. Patients were randomly chosen to receive doses of Ventavis or a non-therapeutic placebo. The researchers learned that about one-fifth of those taking the drug responded to the medications, compared to just 4 percent of those in the group given a placebo. The drug reduced disease severity, helped patients improve their walking distance, and stabilized the cases of PH for those who took it, as the investigators set out to determine. At the end of the study, patients taking the medicine were able to walk 40 meters (nearly 48 yards) farther than those taking the placebo, the researchers found. A Rare Lung Illness
PH is estimated to affect approximately 50,000 people in the United States, 15,000 of whom have been diagnosed and prescribed treatment, according to CoTherix. It is a rare lung disorder in which the blood pressure in the pulmonary artery rises to abnormally high levels. Symptoms include chronic fatigue, shortness of breath, chest pain, fainting, swollen ankles, and abdominal fluid build-up.2 Current therapy includes a range of medications to alleviate constricted pulmonary vessels like calcium channel blockers, epoprostenol (Flolan), Remodulin (treprostinil), and warfarin (Coumadin). For those who aren't responsive to medication, a lung transplant may be the only option, experts say.3 1. PH Neighborhood. Flolan Vs Remodulin. Available at: http://www.phneighborhood.com/content/treatment_options
/medications_for_ph_289.aspx. Accessed February 3, 2005.
2. Pulmonary Hypertension Fact Sheet. Centers for Disease Control and Prevention (CDC). Available at: http://www.cdc.gov/cvh/
library/fs_pulmonary_hypertension.htm. Accessed February 3, 2005.
3. Nauser TD, Stites SW. Diagnosis and treatment of pulmonary hypertension. Am Fam Physician 2001 May 1;63(9):1789-98.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
FDA says Encysive lung drug "approvable"
Mar 24, 2006 - WASHINGTON (Reuters) - Encysive Pharmaceuticals Inc.'s drug Thelin is "approvable" for treating a rare, often-fatal lung condition, a U.S. Food and Drug Administration (FDA) spokeswoman said on Friday.
The FDA sent an "approvable letter" to the company saying Thelin could be approved if certain conditions were met, FDA spokeswoman Susan Cruzan said. She did not disclose the conditions.
The Houston-based company is seeking permission to sell Thelin for treating pulmonary arterial hypertension (PAH), which causes severe shortness of breath and often kills.
The failure to win full approval for Thelin will likely be viewed as positive for Swiss biotechnology company Actelion, which relies heavily on its PAH treatment Tracleer to sustain growth.
"Any delay would provide an upside to our Tracleer forecasts," Kepler Equities analyst Denise Anderson said in a note to clients.
While Tracleer once had the PAH market pretty much to itself, it is now facing increased competition from Pfizer Inc.'s Revatio, which contains the same active ingredient as Viagra.
Thelin would be another direct competitor for treating the rare condition that often leads to the need for a heart and lung transplant.
A fourth drug for PAH called ambrisentan is being developed by Myogen Inc..
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