Biotech Calendar: 2011 FDA Drug Approvals
Additional drugs with potential regulatory milestones in 2011:
Onyx Pharmaceuticals (ONXX)
Drug/indication: carfilzonib for multiple myeloma
Status: FDA approval filing expected mid-2011
Alimera Sciences (ALIM) and pSivida (PSDV)
Drug/indication: Iluvien for diabetic macular edema
Status: FDA rejected Iluvien in December; Alimera intends to resubmit for approval this year based on new, longer-term data.
Genzyme (GENZ) and Isis Pharmaceuticals (ISIS)
Drug/indication: mipomersen for severe hypercholesterolemia
Status: Genzyme is in the process of being acquired by Sanofi-Aventis, which may affect the regulatory timelines for mipomersen. Genzyme had previously suggested that the mipomersen approval filing could be delayed until the second half of 2011, from the previous estimate of a filing in the first half 2011.
Drug/indication: Levadex for migraines
Status: MAP intends to file for Levadex approval in the first half of 2011. Vivus (VVUS)
Drug/indication: Qnexa for obesity
Status: FDA rejected Qnexa in October. Vivus intends to resubmit Qnexa to FDA in 2011. Amylin Pharmaceuticals (AMLN), Alkermes (ALKS) and Eli Lilly (LLY)
Drug/indication: Bydureon for diabetes
Status: Additional clinical work required by FDA after October rejection is ongoing. Resubmission expected by end of 2011. Alexza Pharmaceuticals (ALXA)
Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder
Status: Alexza plans to resubmit AZ-004 to FDA in July 2011. --Written by Adam Feuerstein in Boston.
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