FDA Approvals: BAXDELA, HAEGARDA, RITUXAN HYCELA – Drug and Device Digest

FDA BRIEF: Week of June 19, 2017

FDA approved

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BAXDELA (delafloxacin) Tablets and Injection 

Melinta Therapeutics

INDICATION: Treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:

Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillinsusceptible [MSSA] isolates), Staphylococcus haemolyticus, taphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis.

Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

ADDRESSING UNMET NEED: Antibacterial product treating serious or life-threatening infections


  • Qualified infectious disease product (QIDP)  under Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act
  • Fast Track Designation, Priority Review
  • Postmarketing Requirements: Surveillance for resistance, tissue distribution

MECHANISM OF ACTION: Fluoroquinolone class of antibacterial drugs,  antibacterial activity due to inhibition of both bacterial topoisomerase IV and DNA gyrase
(topoisomerase II) enzymes for DNA replication, transcription, repair, recombination.


  • 2 multicenter, multinational, double-blind, double-dummy, non-inferiority trials. (n=1510), adults with ABSSSI, BAXDELA vs. comparator (intravenous combination of vancomycin and aztreonam)
  • Objective Clinical Response: 20% or greater decrease in lesion size determined by digital planimetry of the leading edge of erythema 48 to 72 hr post initiation.
  • Investigator Assessment of response was made at Follow-up (Day 14 ± 1)
  • Positive Clinical Response and Investigator Assessments in both trials


  • Boxed Warning:  Increased risk of disabling and potentially irreversible serious adverse reactions that have occurred together including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.
  • Contraindication: Hyersensitivity to fluoroquinolones
  • Adverse reactions: Nausea, diarrhea, headache, transaminase elevations (an enzyme that is an indicator of liver injury) and vomiting


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HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human])

CSL Behring 

INDICATION:  Plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH)  indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.


  • HAE patients have absence or low levels of endogenous or functional C1-INH
  • HAEGARDA replaces missing or malfunctioning C1-INH protein
  • First C1-INH for subcutaneous  administration for rare genetic disease


  • Orphan Drug Designation

DESCRIPTION: Human plasma-derived, purified, pasteurized, lyophilized (freeze-dried) concentrate prepared from large pools of human plasma from U.S. donors.


  • A multicenter, randomized, double-blind, placebo-controlled, crossover study (n=90), 16-week treatment period, HAEGARDA (2 doses) vs placebo
  • Efficacy Endpoint: Time-normalized number of HAE attacks (the rate of attacks) relative to placebo
  • Significant decreases with both doses (p<0.001); median reduction 89%, 95%
  • Responders (95% CI) with a ≥50% reduction vs placebo was 83% (73%, 90%)
  • Significant decrease in time-normalized number of uses of rescue medication


  • Most common side effects: Injection site reactions, hypersensitivity reactions, nasopharyngitis and dizziness


RITUXAN HYCELA (rituximab and hyaluronidase human) injection


INDICATION: For the treatment of Follicular Lymphoma (FL),  diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL)

Indicated for the following previously approved indications for Rituxan:

  • Relapsed or refractory FL as a single agent
  • Previously untreated FL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
  • Non-progressing (including stable disease), FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated DLBCL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
  • Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).


  • Subcutaneous route of administration that shortens administration time to 5 to 7 minutes vs. several hours for intravenous infusion
  • Provides for flat dosing.



  • Rituximab is monoclonal antibody targeting CD20 antigen and mediates B-cell lysis
  • Hyaluronidase increases permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan


  • Based on Pharmacokinetic (PK) results
  • Non-inferior rituximab trough concentrations (Ctrough) levels for Rituxan Hycela 1,400 mg/23,400 Units compared to a intravenous rituximab 375 mg/m2
  • NBon-inferior rituximab Ctrough levels for Rituxan Hycela 1,600 mg/26,800 Units compared to intravenous rituximab 500 mg/m2
  • Comparable Overall Response, Progression Free Survival, Overall Survival Rates of Rituxan vs, Rituxan Hycela


  • Boxed Warning: Severe mucocutaneous reactions, Hep B Virus reactivation, progressive multifocal leukoencephalopathy
  • Most common adverse events: FL- infections, neutropenia, nausea, constipation, cough, and fatigue, DLBCL-infections, neutropenia, alopecia, nausea, and anemia, CLL- infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema


Image Credits: Melinta, CSL Behring, Genentech

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