MannKind’s Technosphere® Inhalation Platform Utilized in FDA-Approved Tyvaso DPI™
- Tyvaso DPI represents the second FDA-approved product utilizing MannKind’s Technosphere® inhalation technology
- First approval of a dry powder inhaled treatment for PAH and PH-ILD
- Manufacturing of Tyvaso DPI for United Therapeutics underway at MannKind’s
Connecticutfacility with product availability expected in June 2022
“We are elated that Tyvaso DPI has received approval from the FDA, which paves the way for patients to receive treprostinil in a new and convenient way,” said
“This approval is a result of the hard work of the research, development, regulatory, and operations teams at
PAH is a life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly in afflicted patients. PAH affects an estimated 45,000 patients in
About TYVASO® (treprostinil) Inhalation Solution and TYVASO DPI™ (treprostinil) Inhalation Powder
Eyebrow (abbreviated) Indication
- For the treatment of pulmonary arterial hypertension (PAH;
WHO Group1) to improve exercise ability.
- For the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD;
WHO Group3) to improve exercise ability.
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of:
- Pulmonary arterial hypertension (PAH;
WHO Group1) to improve exercise ability. Studies with TYVASO establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration.
- Pulmonary hypertension associated with interstitial lung disease (PH-ILD;
WHO Group3) to improve exercise ability. The study with TYVASO establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group3 connective tissue disease (22%).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.
- Both products inhibit platelet aggregation and increase the risk of bleeding.
- Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.
- Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI.
DRUG INTERACTIONS/SPECIFIC POPULATIONS
- The concomitant use of either product with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
- Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
- Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
- Safety and effectiveness in pediatric patients have not been established.
- Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH-ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.
- Pulmonary Arterial Hypertension (
In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (
WHO Group1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.
In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥4% of PAH patients during the 3-week treatment phase included cough (35.3%), headache (15.7%), dyspnea (7.8%), and nausea (5.9%).
- Pulmonary Hypertension Associated with ILD (
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (
WHO Group3), adverse reactions with TYVASO were similar to the experience in studies of PAH.
Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.TYVASOHCP.com or call 1-877-
AFREZZA, DREAMBOAT and TECHNOSPHERE are registered trademarks of
TYVASO is a registered trademark of United Therapeutics Corporation.
TYVASO DPI is a trademark of United Therapeutics Corporation.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6aefefbf-ad43-4477-8d59-f06f764ec3b6
MannKind: Christie Iacangelo, Corporate Communications (818) 292-3500 Email: firstname.lastname@example.org Rose Alinaya, Investor Relations (818) 661-5000 Email: email@example.com
MannKind celebrates that the FDA has approved United Therapeutics’ Tyvaso DPI™ (treprostinil) inhalation powder
Tyvaso DPI™ production is underway at
MannKind Corporation (Nasdaq: MNKD) in Danbury, Conn. On May 24, 2022, MannKind celebrated that the U.S. Food and Drug Administration (FDA) has approved United Therapeutics’ Tyvaso DPI™ (treprostinil) inhalation powder. Tyvaso DPI represents the second FDA-approved product utilizing MannKind’s innovative Technosphere® inhalation technology. MannKind and United Therapeutics (Nasdaq: UTHR) entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI.