FDA Calendar Updates: Roche, United Therapeutics

Written by Mike Havrilla

Thursday, 30 July 2009 09:57

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 288 entries as of 7/30/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/30/09, United Therapeutics (NASDAQ: UTHR ) announced that the FDA has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories). TYVASO is indicated to increase walk distance in patients with NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

In connection with the TYVASO approval, UTHR has agreed to Post-Marketing Commitments (PMC) no later than 10/31/10 to modify certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify expected dosing with the modified device. Additionally, UTHR has agreed to a Post-Marketing Requirement (PMR) no later than 12/15/13 to conduct a long-term observational study to evaluate the risk of oropharyngeal and pulmonary toxicities among patients using TYVASO.

United Therapeutics plans to launch TYVASO in conjunction with its wholly-owned subsidiary, Lung Rx, Inc., in the United States at the beginning of September 2009.

On 7/30/09, Roche (VTX:ROG) (RHHBY.PK) announced that Lucentis was effective in helping to improve the vision in patients suffering from a condition known as central retinal vein occlusion (RVO). This was the second six-month, late-stage study of Lucentis for RVO to deliver statistically significant results showing vision improvement compared with a placebo. The drug (originally developed by Genentech) is currently approved to treat wet age-related macular degeneration, which is the leading cause of blindness in the elderly.

Data from the two studies will be used in seeking expanded Lucentis approval for treatment of RVO in the form of a supplemental Biologic License Application (sBLA). Genentech estimates that about 868,000 people suffer from branch RVO and 259,000 have central RVO in the United States, fewer than those with age-related macular degeneration. Lucentis had sales of $875 million in 2008.

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