UK NICE backing for Celgene and Janssen multiple myeloma drugs, Thalidomide and Velcade; FDA fast-tracks Istodax sNDA

In final draft guidance published on Friday, UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) recommends two treatments for multiple myeloma: USA biotech firm Celgene’s  (Nasdaq: CELG) Thalidomide (thalidomide) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag’s Velcade (bortezomib). The NICE issued a positive draft guidance on both drugs earlier this month (The Pharma Letter June 3).

Publication of this latest draft follows an appeal by the manufacturer of bortezomib, Janssen. The appeal panel met in November and upheld one of seven appeal points, stating that insufficient efforts had been made by the NICE to obtain permission to release an executable economic model to consultees. Following this decision, the NICE worked with the owners of confidential data contained in the model and they agreed its release to consultees. The appraisal committee met again to discuss comments received on the reliability of the model and to reconsider the draft recommendations. Following the discussion, the guidance remains unchanged:

Velcade second choice therapy