Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 240 entries as of 7/6/09. 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 7/5/09, Spectrum Pharma (NASDAQ:SPPI)
announced that it has received a Complete Response Letter (CRL) from the FDA for its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.
The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. SPPI highlighted the following regarding the CRL for Zevalin:
- No additional clinical studies have been requested;
- The additional data requested do not involve new data analyses; and
- The Company plans to formally respond to the FDA’s requests by 7/8/09.
CRL Resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline is calculated from the resubmission date (i.e. no later than Weds. 7/8 according to SPPI).
On 7/6/09, Oxford BioMedica (OTC:OXBDF)
announced that the FDA has approved the Company's plans to further develop its cancer vaccine candidate TroVax despite it missing a primary endpoint last year in a Phase 3 renal cancer trial. The FDA has invited submissions of adaptive Phase II/III trial designs in metastatic colorectal cancer being carried out by the Company's development partner Sanofi-Aventis (NYSE:SNY)
On 7/6/09, Protalix BioTherapeutics (AMEX:PLX)
announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms.
prGCD, the Company’s lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease. The FDA indicated to the Company that it believes the Company’s development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug (IND) application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.
On 7/6/09, Shire (NASDAQ:SHPGY) announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease. If approved by the FDA, the treatment protocol would allow physicians to treat Gaucher Disease patients with velaglucerase alfa ahead of commercial availability in the U.S.
Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible. Velaglucerase alfa is made with Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern. Shire is working with the FDA to file a NDA for velaglucerase alfa as soon as possible.
Disclosure: No positions.