MannKind’s Technosphere® Inhalation Platform Utilized in FDA-Approved Tyvaso DPI™
May 24 2022 - 6:00AM
MannKind Corporation (Nasdaq: MNKD), a company
focused on the development and commercialization of innovative
therapeutic products for patients with endocrine and orphan lung
diseases, celebrated today that the U.S. Food and Drug
Administration (FDA) has approved United Therapeutics’ Tyvaso DPI™
(treprostinil) inhalation powder for the treatment of patients with
pulmonary arterial hypertension (PAH) and pulmonary hypertension
associated with interstitial lung disease (PH-ILD). Tyvaso DPI
represents the second FDA-approved product utilizing MannKind’s
innovative Technosphere® inhalation technology and is the first and
only approved dry powder inhaled treatment for these indications.
“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 Michael Castagna, PharmD, Chief
Executive Officer of MannKind Corporation. “This approval
exemplifies MannKind’s commitment to developing products that give
people control of their health and the freedom to live life. With
Tyvaso DPI, patients can potentially fit in the palm of their hand
a full day of dosing treprostinil from a Dreamboat® inhaler.”
“This approval is a result of the hard work of the research,
development, regulatory, and operations teams at MannKind and
United Therapeutics,” said Patrick Poisson, Executive Vice
President of Technical Operations at United Therapeutics. “We are
thrilled to provide a dry powder inhaled alternative to liquid
nebulization of Tyvaso.”
MannKind and United Therapeutics entered into a worldwide
exclusive licensing and collaboration agreement in September 2018
for the development and commercialization of Tyvaso DPI. In August
2021, the two companies established a commercial supply agreement
that has an initial term through 2031. A next-generation
formulation of treprostinil, Tyvaso DPI incorporates the dry powder
formulation technology and Dreamboat inhalation device technology
used in MannKind’s Afrezza® (insulin human) Inhalation Powder,
which was approved by the FDA in 2014. Tyvaso DPI is produced at
MannKind’s manufacturing facility in Connecticut.
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 the United States. ILD is a group of lung diseases in
which marked scarring occurs within the lungs. It is often
complicated by pulmonary hypertension (PH), which furthers symptoms
and decreases survival. PH is estimated to affect at least 15% of
patients with early-stage ILD (approximately 30,000 PH-ILD patients
in the United States) and may affect up to 86% of patients with
more severe ILD. Tyvaso® and Tyvaso DPI are the only therapies
approved by the FDA to treat PH-ILD.
About TYVASO®
(treprostinil) Inhalation Solution and TYVASO DPI™
(treprostinil) Inhalation Powder
Eyebrow (abbreviated) Indication
- For the treatment of pulmonary
arterial hypertension (PAH; WHO Group 1) to improve exercise
ability.
- For the treatment of pulmonary
hypertension associated with interstitial lung disease (PH-ILD; WHO
Group 3) to improve exercise ability.
INDICATION
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI
(treprostinil) Inhalation Powder are prostacyclin mimetics
indicated for the treatment of:
- Pulmonary arterial hypertension (PAH; WHO Group 1) 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 Group 3) 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 Group 3
connective tissue disease (22%).
IMPORTANT SAFETY INFORMATIONWARNINGS 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.
ADVERSE REACTIONS
- Pulmonary Arterial Hypertension (WHO
Group 1)In a 12-week, placebo-controlled study (TRIUMPH I) of 235
patients with PAH (WHO Group 1 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 (WHO Group 3)In a 16-week, placebo-controlled study
(INCREASE) of 326 patients with PH-ILD (WHO Group 3), 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-UNITHER
(1-877-864-8437).
TYVISIhcpMAY2022
About MannKind CorporationMannKind Corporation
(Nasdaq: MNKD) focuses on the development and commercialization of
therapeutic and convenient products for patients with endocrine and
orphan lung diseases. MannKind is currently commercializing
Afrezza® (insulin human) Inhalation Powder, the Company’s first
FDA-approved product and the only inhaled ultra rapid-acting
mealtime insulin in the United States, where it is available by
prescription from pharmacies nationwide. Afrezza is also available
by prescription in Brazil, where it is commercialized by the
Company’s partner, Biomm SA. MannKind was established in 1991, and
is located in Danbury, Conn., and Westlake Village, Calif. The
Company also employs field sales and medical representatives across
the U.S. Please visit mannkindcorp.com to learn more.
AFREZZA, DREAMBOAT and TECHNOSPHERE are registered trademarks of
MannKind Corporation.
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
For MannKind:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: media@mannkindcorp.com
Rose Alinaya, Investor Relations
(818) 661-5000
Email: ir@mannkindcorp.com
MannKind (NASDAQ:MNKD)
Historical Stock Chart
From Aug 2024 to Sep 2024
MannKind (NASDAQ:MNKD)
Historical Stock Chart
From Sep 2023 to Sep 2024