News and Comments

What Could Happen To HGSI’s SLE Drug On Tuesday?

  Monday, November 15, 2010

A few days before the independent FDA committee review of Human Genome Sciences’ (HGSI) systemic lupus erythematosus (SLE) drug Benlysta (belimumab), the FDA suggested that the drug has marginal efficacy and scary adverse effects. The agency expressed concerns about infection, neuropsychiatric complications, including the risk of suicide, and increased risk of death as a result of the use of the drug. The FDA message to the independent committee, which will convene on Tuesday, is to decide whether the reward is worth the high risk. The FDA has also observed that studies conducted outside the U.S. produced stronger data than the U.S.; these studies were not consistent with the U.S. results. The agency has also observed that the African-American lupus patients had benefited less from Benlysta than did non-African American patients.  More...


Recent Postings


Archive


Tags

Zerenex Vertex (VRTX) GlaxoSmithKline (GSK) Sanofi-Aventis (SAN) Bellicum (BLCM) Sangamo (SGMO) Exelixis (EXEL) Inovio (INO) Ariad (ARIA) Agenus (AGEN Advaxis (ADXS) PTC Therapeutics (PTCT) KITE (KITE) Onyx (ONXX) VANDA (VNDA) Agenus (AGEN) IDERA (IDRA) Velcade (bortezomib) ImmunoGen (IMGN) AERIE PHARMACEUTICALS NEKTAR (NKTR)) Trastuzumab-DM1 Array Pharmaceuticals (ARRY) Idenix (IDIX) Pluristem (PSTI) ACADIA (ACAD) SYNTA (SNTA) Editas (EDIT) Benlysta (belimumab) Roche (RHHBY) Theravance (THRX) Human Longevity (HLI) Dendreon (DNDN) Intermune (ITMN) Auspex (ASPX) RenenxBio (RGNX) Tysabri Ridaforolimus Theravance Bio Pharma (TBPH) NOVOCURE (NVCR) Prolor Biotech (PBTH) Biogen Idec (BIIB) Telaprevir TOKAI (TKAOI) Ionis (IONS) Ziofpharm (ZIOP) Aimmune Therapeutics (AIMT) REGULUS (RGLS) Rapamune Intrexon (XON) ARCA (ABIO) Galena (GALE) Mirati Therapeutics (MRTX) Cytokinetics (CYTK) Alder Biopharmaceuticals (ALDR) Micromet (MITI) AGOS (ARGS) Intercept (ICPT) Seattle Genetics (SGEN) Sarepta (SRPT) Spike Therapeutics (ONCE) GUARDIAN HEALTH NANTKWEST (NK) Valeant Pharmaceuticals International (VRX) ARGOS (ARGS) Roche (ROCHE) Jazz Pharmaceuticals (JAZZ) Elan (ELN) OSI (OSIP) Illumina (ILMN) Anadys (ANDS) Multiple Myeloma SUNESIS PHARMACEUTICALS (SNSS) MODERNA Genentech Global Cell Therapeutics (GBT) Sanofi (SNY) JUNO (JUNO) Merck (MRK) Amgen (AMGN) Human Genome Sciences (HGSI) CompuGen (CGEN) C4 Therapeutics ISIS (ISIS) Regeneron (REGN) ADVENTRIX (ANX) BIOMARIN (BMRN) Vitae Pharmaceuticals (VTAE) Sequenom (SQNM) Revlimid (lenolidamide) Dynavax (DVAX) Adaptimmune (ADAP) ABBVIE (ABBV) INNOVIVA (INVA) Prosensa (RNA) Sanofi (SNA) Herceptin HALOZYME (HALO) Alnylam (ALNY) AstraZeneca (AZN) Bristol-Myers Squibb (BMY) KERYX (KERX) Anacor (ANAC) Biocryst (BCRX) Gilead (GILD) galapagos (GLPG) SERES THERAPEUTICS (MCRB) Xoma (XOMA) Abbott Laboratories (ABT) Incyte (INCY) Endometrial Cancer ZALTRAP™