YUPELRI delivers a full 24 hours of efficacy in a single, nebulized, daily dose1

YUPELRI was studied in two 12-week, randomized, double-blind, placebo-controlled, parallel-group confirmatory studies (Studies 1 and 2) to evaluate the efficacy of once-daily YUPELRI vs placebo in patients with moderate to very severe COPD

Consistent improvement in FEV1 vs placebo over 24 hours on days 84/851,11

Chart showing difference between YUPELRI and placebo in FEV1 over 24 hours on days 84/85 as described in detail below.

In Studies 1 and 2, serial spirometry was performed on a substudy population. Pooled results are shown. Primary efficacy endpoint was change from baseline in trough (predose) FEV1 at day 85 vs placebo.

  • In Studies 1 and 2, a prespecified exploratory analysis was performed. In Study 1, LS mean changes from baseline in FEV1 ranged from 55.8 mL to 240.4 mL in the YUPELRI group, and from -113.6 mL to 59.6 mL in the placebo group. In Study 2, LS mean changes from baseline in FEV1 ranged from 19.8 mL to 148.5 mL in the YUPELRI group, and from -176.4 mL to -13.0 mL in the placebo group11

LS=least squares.

In the 2 pivotal clinical studies, YUPELRI demonstrated

Once-daily dosing1
Responses in as early as
30 minutes11*
24-hour control1

*An exploratory analysis of the time to achieve a 100 mL increase in FEV1 on day 1 showed that the median (95% CI) time to achieve an increase in FEV1 of 100 mL was 30 minutes in Study 1 (30 to 60 minutes) and Study 2 (30 to 90 minutes).11

YUPELRI delivers consistent control* over 12 weeks

Consistent improvements† in trough FEV1 over the 12-week study period1,11

Chart showing consistent improvements in trough FEV1 over 12-week study period between YUPELRI vs. placebo as described in detail below

Pooled data from Studies 1 and 2. Primary efficacy endpoint: change from baseline in trough (predose) FEV1 at day 85 vs placebo.1 A secondary endpoint, overall treatment effect (OTE), showed trough FEV1 across the 12-week study.

*See below for Studies 1 and 2: Primary endpoints.
†First measurement was taken at 2 weeks.11
LS=least squares.
‡LS mean difference from placebo (SE) is 148.13 mL (16.782) pooled estimate adjusts the LS mean for placebo as well.11

Studies 1 and 2: Primary endpoints1,11

  • In Study 1, LS mean change from baseline in trough FEV1 on day 85 was 127 mL (YUPELRI, n=189) and -19 mL (placebo, n=191), with a statistically significant difference vs placebo of 146 mL (P<0.0001)
  • In Study 2, LS mean change from baseline in trough FEV1 on day 85 was 102 mL (YUPELRI, n=181) and -45 mL (placebo, n=187), with a statistically significant difference vs placebo of 147 mL (P<0.0001)

Studies 1 and 2: Patient characteristics1

  • Mean age of 64 years (range, 41-88 years)
  • Mean smoking history of 53 pack-years (48% current smokers)
  • Moderate to very severe COPD (mean post-bronchodilator % predicted FEV1 of 55%)
  • 37% of patients studied were on concomitant LABA or ICS/LABA therapy 

YUPELRI improved lung function over 12 weeks in concomitant use with LABA or ICS/LABA and as monotherapy11

Studies 1 and 2: Pooled subgroup analysis11

LS mean difference in trough FEV1 over 12-weeks

Chart showing LS mean difference in trough FEV1 over 12 weeks concomitant use data between YUPELRI with concomitant LABA or ICS/LABA vs. placebo with concomitant LABA or ICS/LABA as described in detail below

These pooled analyses are adequately powered and robust (derived from appropriate statistical tests, prespecified in the statistical analysis plan, with type 1 error controlled using a hierarchical testing strategy), allowing for conclusions to be drawn about the OTE of YUPELRI in patients with or without concomitant LABA containing therapy (ie, LABA or LABA/ICS).

YUPELRI with concomitant LABA or ICS/LABA vs placebo with concomitant LABA or ICS/LABA11§:

  • LS mean change from baseline in trough FEV1 on day 85 was 111.82 mL (YUPELRI, n=118) and -27.37 mL (placebo, n=89) (P<0.0001)
  • LS mean difference from placebo was 139.19 mL (95% CI, 82.87-195.51)

YUPELRI only vs placebo only (data not shown in graph above):

  • LS mean change from baseline in trough FEV1 on day 85 was 117.66 mL (YUPELRI, n=192) and -33.27 mL (placebo, n=207) (P<0.0001)
  • LS mean difference from placebo was 150.93 mL (95% CI, 110.26-191.61)

§Note: The safety and efficacy of mixing therapies with YUPELRI in a nebulizer have not been established.

Health-related quality of life (HRQoL) with once-daily YUPELRI

  • In Study 1, the St. George’s Respiratory Questionnaire (SGRQ) responder rate for the YUPELRI treatment arm on day 85 was 49% compared to 34% for placebo (odds ratio=2.11; 95% CI, 1.14-3.92) 1,18||
  • In Study 2, the SGRQ responder rate for the YUPELRI treatment arm was 45% compared to 39% for placebo (odds ratio=1.31; 95% CI, 0.72-2.38)1
  • The clinical relevance of this data is unknown

||SGRQ is a validated, patient-reported, disease-specific instrument designed to measure symptom improvement, activities of daily living, and social interaction for a total score. A change of 4 units improvement in the SGRQ is considered a minimum clinically important difference.

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Indication

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YUPELRI® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Important Safety Information

YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.

YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, or for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with YUPELRI, it should be treated immediately with an inhaled, short-acting bronchodilator. YUPELRI should be discontinued immediately and alternative therapy should be instituted.

YUPELRI should be used with caution in patients with narrow-angle glaucoma. Patients should be instructed to immediately consult their healthcare provider if they develop any signs and symptoms of acute narrow-angle glaucoma, including eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema.

Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

Immediate hypersensitivity reactions may occur after administration of YUPELRI. If a reaction occurs, YUPELRI should be stopped at once and alternative treatments considered.

The most common adverse reactions occurring in clinical trials at an incidence greater than or equal to 2% in the YUPELRI group, and higher than placebo, included cough, nasopharyngitis, upper respiratory infection, headache and back pain.

Coadministration of anticholinergic medicines or OATP1B1 and OATP1B3 inhibitors with YUPELRI is not recommended.

YUPELRI is not recommended in patients with any degree of hepatic impairment.

For additional information, please contact us at 1-800-395-3376.

For additional information, please contact us at 1-800-395-3376.