FDA Approvals: Zepatier®, Halaven® – Drug and Device Digest

FDA Brief: Week of Jan 25, 2016

FDA approved


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ZEPATIER, (fixed dose combination product of elbasvi and grazoprevir) tablets

Merck , Whitehouse Station, New jersey, USA

Indication : With or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults

Unmet Need :

  • Hepatitis C can lead to diminished liver function or liver failure
  • Most infected people asymptomatic until liver damage becomes apparent
  • 3 million Americans are infected with HCV, of which genotype 1 is the most common and genotype 4 is one of the least common
  • The approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon.

Reg Pathway : Breakthrough Therapy designation, Priority Review

Mechanism of Action: Direct-acting antiviral agents against the hepatitis C virus


  • Six studies(n=1,373), open label and double-blind, with or without ribavirin, with or without cirrhosis, 12-16 weeks
  • Sustained virologic response (SVR) 12 weeks post-treatment : 94-97 % (genotype-1) and 97-100 % (genotype-4)
  • To maximize SVR rates :  Label provides recommendations regarding length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and their virus


  • Warning : Elevations of liver enzymes
  • Most common side effects: Fatigue, headache, nausea. With ribavirin, anemia and headache.



HALAVEN  ( eribulin mesylate ) injection

Eisai, Woodcliff Lake, New Jersey, USA


Indication : Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

Unmet Need:

  • Liposarcoma is a  Soft Tissue Sarcoma(STS) in fat cells
  • STS most common in the head, neck, arms, legs, trunk and abdomen
  •  12,000 cases of STS diagnosed in US
  • Need for therapy with survival benefit

Reg Pathway : sNDA, Orphan Drug designation, Priority Review

Mechanism of Action : Inhibits growth phase of leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.


  • Single open-label, randomized, active-controlled trial (n=446.), patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma, at least two prior systemic chemotherapies (containing anthracyclis) , Halaven vs dacarbazine
  • Overall Survival : Statistically significant improvement (p=0.011)
  • Progression-free survival: No significant difference in overall population
  • No evidence of with advanced or metastatic leiomyosarcoma


Safety :

  • Most common Serious Adverse Reactions: Neutropenia, Pyrexia
  • Most frequent Adverse Reactions leading to Discontinuation: Fatigue, thrombocytopenia.
  • Most common Adverse Reactions: Fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia

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