FDA, Clinical Trial Updates: BIIB, SLXP, CTIC, PFE, Roche
Posted on: May 26, 2009 - Email Article - Printable Version
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
On 5/19/09, Biogen [BIIB: 58.76, -0.02 (-0.03%)] and Genentech (acquired by Roche) [RHHBY: 0.00, N/A (N/A)] announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months for an estimated PDUFA decision date of 11/19/09.
The applications are based on positive results from two of the largest global Phase 3 clinical trials conducted in patients with CLL, which showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (progression-free survival or PFS) compared to those receiving chemotherapy alone.
In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69% improvement in PFS (41 percent risk reduction, hazard ratio=0.59; p<0.0001; 95% confidence interval: 0.44,0.72) compared to those who received chemotherapy alone. In REACH, patients whose cancer relapsed after previous treatment had a 54% improvement in PFS after receiving Rituxan plus chemotherapy compared to patients receiving chemotherapy alone (35 percent risk reduction, hazard ratio=0.65; p=0.0002; 95% confidence interval: 0.51, 0.82).
Salix Pharma [SLXP: 31.96, +1.08 (+3.50%)]: A U.S. advisory panel on Tuesday rejected a Debiovision Inc drug to treat a dangerous type of bleeding in the esophagus. The FDA advisory committee voted 14-0 that current data did not show that the benefits of the drug, Sanvar (vapreotide), outweighed potential risks. SLXP is the U.S. marketing partner for Swiss-based Debiopharm, which filed its complete response to the FDA on 11/4/08 in response to an earlier approvable letter for Sanvar. The immediate release formulation of Sanvar, a somatostatin analogue, is used in the treatment of a condition known as acute esophageal variceal (veins) bleeding.
Cell Therapeutics [CTIC: 0.9718, -0.025 (-2.51%)]: CTIC released updated safety data on 5/19/09 from its pixantrone Phase 3 EXTEND clinical trial which demonstrated the effectiveness of pixantrone in patients with relapsed/refractory aggressive non-Hodgkin’s lymphoma (NHL) for whom anthracycline-related drugs are typically not to be used due to the increased risk of cardiac failure.
As noted during the presentation of Craig Philips, President of CTI, “The standard chemotherapy regimen (CHOP) for this disease exposes patients to less than or equal to 300mg/m2 of doxorubicin, a dose at which 5.6% of patients are expected to develop congestive heart failure (CHF). At cumulative doses of doxorubicin in excess of 600mg/m2, 48% of patients develop CHF.” At a cumulative total doxorubicin equivalent exposure of > 600mg/m2, the frequency of CHF among PIX 301 recipients was 4% compared to 48% reported for doxorubicin.
Pfizer [PFE: 17.08, -0.21 (-1.21%)]: PFE announced on 5/19/09 that the addition of Lyrica (pregabalin) capsules to other generalized anxiety disorder (GAD) treatments significantly improved the symptoms of the condition in patients who responded only partially to previous treatments, according to a study presented at the American Psychiatric Association annual meeting. In this study, patients treated with Lyrica showed significant improvements in both their psychological and physical symptoms of anxiety. According to the Company’s press release, this is the first large, placebo-controlled trial to demonstrate the efficacy of an add-on therapy strategy in patients who had failed to respond to two different courses of GAD mono-therapy with a SSRI, SNRI, or benzodiazepine.
The study found that patients treated with Lyrica in addition to their baseline SSRI/SNRI therapy had a significantly greater improvement in overall anxiety symptoms as well as individual psychological and physical symptoms compared to baseline therapy alone as measured by the Hamilton Anxiety Scale (HAM-A), an interview scale that measures the severity of a patient’s anxiety. Over the eight week treatment period, patients receiving add-on Lyrica therapy had, on average, an anxiety score that was 1.2 points lower on the HAM-A compared to baseline therapy alone (P=0.012). Significantly more patients receiving add-on Lyrica treatment (50 percent) showed at least a 50% reduction in their anxiety symptoms compared to SSRI/SNRI treatment alone (37 percent) (P=0.023). Lyrica was also shown to be well tolerated as an add-on therapy in this study.
- Mike Havrilla
Disclosure: This article is taken from the website BioMedReports with the permission of the original author. All questions regarding disclosure should be referred to the original author.
The Following Stocks Were Mentioned In This Article: BIIB, CTIC, PFE, PHHBY, SLXP
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