FDA Brief: Week of Mar 21, 2016

FDA approved


 

ANTHIM (obiltoxaximab) injection

Elusys Therapeutics, New Jersey, USA

Indication: In adult and pediatric patients

  •  For  treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs
  • For prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate [see Indications and Usage

Unmet Need:

  • Rare disease caused by breathing spores of bacterium Bacillus anthracis
  • Bacterial toxins produce massive and irreversible tissue injury and death
  • Potential bioterrorism threat

Reg Strategy: BLA, approved under the FDA’s Animal Rule, Developed in in conjunction with the U.S. DHHS Biomedical Advanced Research and Development Authority (BARDA)

Mechanism of Action: Monoclonal antibody that neutralizes toxins produced by B. anthracis.

Efficacy:   Rabbits (2 studies) and cynomolgus macaque (2 studies) as it is not feasible or ethical  for human studies; with systemic anthrax; placebo controlled

  • Survival : Significant improvement (p<0.01-0.001)  in survival relative to placebo
  • Survial (in combination with antibiotics) : Further improvement
  • Survival (prophylaxis treatment): 100%

Safety: 320 healthy human volunteers.

  • Boxed Warning: Hypersensitivity, Anaphylaxis
  • Most frequently reported side effects: Headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.

LABEL


TALTZ (ixekizumab) injection

Eli Lilly, Indiana, USA

Indication:  Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Unmet Need:

  • Autoimmune disorder, with a family history, between ages of 15 and 35
  • Thick, red skin with flaky, silver-white scales
  • Need for treatment option to  relieve the skin irritation and discomfort

Reg. Strategy: BLA, Standard review

Mechanism of Action: Humanized immunoglobulin G subclass 4 monoclonal antibody (mAb) Antibody binds to protein (interleukin -17A) that causes inflammation.

Efficacy:  3 multicenter, randomized, double-blind, placebo-controlled trials, n= 3866, 12 weeks. In 2 trials, subjects also randomized to etanercept for 12 weeks.

  • Greater clinical response than placebo in the 2 co-primary endpoints
  • Psoriasis Area and Severity Index (PASI) 75% reduction:
  • Static Physician Global Assessment (sPGA) 2-pt improvement

Safety: 

  • Medication Guide on greater risk of an infection
  • Serious allergic reactions and inflammatory bowel disease
  • Most common side effects: Upper respiratory infections, injection site reactions and fungal (tinea) infections.

LABEL


CINQAIR (reslizumab) infusion

Teva, Pennsylvania, USA

Indication:  Add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype

Unmet Need:

  • > 22 million in U.S. have asthma, > 400,000 asthma-related hospitalizations/yr
  • Need for another treatment option

 

Reg Strategy: BLA, Standard review

Mechanism of Action: Humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in murine myeloma cells. Reduces blood eosinophils that contribute to asthma.

Efficacy: 4 randomized, double-blind, placebo-controlled studies (n=981), 52 weeks, 12 years of age and older

  • Frequency of asthma exacerbations:  Significant reduction
  • Time to first attack: Significantly longer
  • Improvement in Lung Function (FEV1): Improved

cinqair

lung.JPG

Safety:

  • Can cause serious side effects including allergic (hypersensitivity) reactions
  • Most common side effects: Anaphylaxis, cancer, muscle pain

LABEL


 

 Xalkori (crizotinib) capsules

Pfizer, New York, USA

Indication:  Treatment of patients with metastatic non small-cell lung cancer (NSCLC) whose tumors are ROS1-positive (previously approved for NSCLC with anaplastic lymphoma kinase (ALK)-positive tumors)

Unmet need:

  •  221,200 new diagnoses and 158,040 deaths in US in 2015
  • Difficult to treat, different mutations, some of which are rare
  • Need for treatment option for rare and difficult to treat ROS-1 gene mutation

Reg. Strategy:  SNDA, Breakthrough Therapy designation, Priority Review, Orphan Drug designation

Efficacy: Single, multicenter, single-arm study (n=50), histologically-confirmed advanced NSCLC with a ROS1 rearrangement

  • Objective Response Rate: 66%
  • Duration of Response: 18.3 mo.

Safety:

  • Serious side effects: Liver problems, life-threatening or fatal lung inflammation, abnormal heartbeats, vision loss
  • Most common side effects: Vision disorders, nausea, diarrhea, vomiting, swelling (edema), constipation, liver problems (elevated transaminases), fatigue, decreased appetite, upper respiratory infection, and dizziness and numbness or tingling in the hands or feet

LABEL


 

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