Brensocatib: First FDA-Approved Drug for Non-Cystic Fibrosis Bronchiectasis

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What is Brinsupri (Brensocatib)?

Brinsupri (Brensocatib) is the first FDA-approved treatment for non-cystic fibrosis bronchiectasis (NCFB). It is an oral DPP1 inhibitor that reduces airway inflammation by targeting neutrophil activation.

Key Features

✔ First-in-class DPP1 inhibitor
✔ Once-daily oral tablet (10mg or 25mg)
✔ Reduces exacerbations by 21% (ASPEN trial)
✔ Approved for ages 12+

How Brinsupri Works?

Brinsupri inhibits dipeptidyl peptidase 1 (DPP1), an enzyme that activates neutrophil serine proteases. This leads to:

  1. Reduced neutrophil inflammation in airways
  2. Fewer exacerbations (flare-ups)
  3. Slowed lung function decline

Mechanism Breakdown

TargetEffectOutcome
DPP1 enzymeInhibits neutrophil activationLess airway damage
Neutrophil proteasesReduces enzyme releaseDecreased mucus & inflammation
Chronic inflammationBreaks cycle of infection & flare-upsFewer hospitalizations

Clinical Trial Results (ASPEN & WILLOW Studies)

Efficacy Data

MetricBrinsupri 10mgBrinsupri 25mgPlacebo
Exacerbation Reduction21.1%19.4%Baseline
Time to First ExacerbationSignificantly longerSignificantly longerShorter
Exacerbation-Free PatientsHigher %Higher %Lower %
FEV₁ Decline at 52 WeeksLess declineStatistically significant improvementFaster decline

Safety Profile

Common Side Effects (≥2%):

  • Upper respiratory infection
  • Headache
  • Rash, dry skin, hyperkeratosis
  • Hypertension

Rare but Serious Risks:

  • Gingivitis & periodontal issues
  • Liver enzyme elevations
  • Skin cancer (1.9% in 25mg group)

Who Can Take Brinsupri?

✅ Adults & children (12+) with NCFB
✅ Patients with ≥2 exacerbations/year
❌ Not for cystic fibrosis-related bronchiectasis

Dosage Options

  • 10mg tablet (for moderate cases)
  • 25mg tablet (for severe/recurrent exacerbations)

Availability & Cost

  • Now available in U.S. via specialty pharmacies
  • Expected in EU/UK (2026), Japan filing planned
  • Cost: Not yet disclosed (check Insmed’s inLighten Patient Support Program for assistance)

Brensocatib Side Effects

Based on Phase 3 ASPEN trial data:

  • Upper respiratory tract infections (cold-like symptoms)
  • Headache
  • Skin reactions:
    • Rash
    • Dry skin
    • Hyperkeratosis (thickened skin)
  • Hypertension (high blood pressure)
  • Gingival/periodontal issues (gum inflammation)

Less Common But Serious Risks

1. Dermatologic Reactions

  • Frequency: 5-10% of patients
  • Types:
    • Eczema-like rashes
    • Skin thickening
    • Rare cases of skin cancer (1.9% in 25mg group)
  • Management:
    • Regular skin checks
    • Dermatologist referral for persistent rashes

2. Oral Health Complications

  • Reported in 8-12% of patients
  • Includes:
    • Gingivitis
    • Periodontitis
    • Tooth/gum pain
  • Prevention:
    • Dental exams every 6 months
    • Strict oral hygiene

3. Liver Enzyme Elevations

  • Occurrence:
    • ALT/AST >3x ULN: 0.5-1.2%
    • Alkaline phosphatase >1.5x ULN: 2.5-4.1%
  • Monitoring:
    • Baseline liver tests
    • Repeat at 3/6/12 months

4. Other Notable Effects

  • Alopecia (hair loss) – 1.5-1.6%
  • Hypertension – 3-5%
  • Increased infection risk (avoid live vaccines)

SOURCE Insmed Incorporated

FAQ About Brensocatib

1. How does Brinsupri differ from current bronchiectasis treatments?

Answer: Brinsupri is the first drug targeting DPP1 to reduce neutrophilic inflammation, while current therapies only manage symptoms (antibiotics, mucus clearance).

2. How long does Brinsupri take to work?

Answer: In trials, exacerbation reduction was seen within 24 weeks, with lung function benefits at 52 weeks.

3. Can Brinsupri cure bronchiectasis?

Answer: No—it slows progression and reduces flares but doesn’t reverse existing lung damage.

4. What monitoring is needed on Brinsupri?

Answer: Regular dermatologic checks (for rash/skin cancer) and dental visits (for gum health).

5. Will insurance cover Brinsupri?

Answer: Most insurers will cover it, but copay assistance is available through Insmed’s inLighten program.

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