Silver Spring-based United Terapeutics has announced the First approval of a dry powder inhaler for treatment of PAH and PH-ILD. The DPI device represents a convenient option for administration of treprostinil therapy. Commercial launch activities underway; patient availability expected in June 2022. Per, BizJournals, this has “sent the local drugmaker’s stock soaring.”
Press Release: United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the U.S. Food and Drug Administration (FDA) has approved Tyvaso DPI™ (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.
“Tyvaso DPI is one of the easiest ways for patients to administer a prostacyclin, delivering the proven efficacy of treprostinil through a small inhaler that fits in the palm of the patient’s hand,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “We look forward to launching this exciting new product, and the opportunity to introduce treprostinil to more patients with PAH and PH-ILD.”
“Prostacyclin-based therapies are effective in treating PAH, and recent data from the INCREASEstudy has shown that inhaled treprostinil is an effective treatment for PH-ILD,” said Shelley Shapiro, M.D., Ph.D. at the David Geffen UCLA School of Medicine Pulmonary Hypertension Program. “The convenience and portability of Tyvaso DPI may make it an important new option for patients with WHO Group 1 PAH and with WHO Group 3 PH-ILD, with the potential for improving the quality of life for this patient population.”
PAH is life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly. PAH affects an estimated 45,000 patients in the United States. Interstitial lung disease (ILD) is a group of conditions in which marked scarring occurs within the lungs. It is often complicated by pulmonary hypertension (PH; high blood pressure in the lungs), 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®(treprostinil) Inhalation Solution and Tyvaso DPI are the only therapies approved by the FDA to treat PH-ILD.
FDA approval of the new drug application for Tyvaso DPI is supported by data from BREEZE, an open label study of 51 PAH patients on a stable regimen of Tyvaso Inhalation Solution who were transitioned to Tyvaso DPI. In subjects with PAH, transition from Tyvaso Inhalation Solution to Tyvaso DPI demonstrated safety and tolerance during the three-week treatment phase with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes. Top line data from BREEZE were issued in January 2021, efficacy data were presented in September 2021, long-term open-label safety data were published in April 2022, and additional long-term safety and efficacy data were presented in May 2022. See the Important Safety Information below under “About Tyvaso DPI”.
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17th Annual Kensington Day of the Book Festival
Now in its 17th year, the Kensington Day of the Book Festival is a family-friendly street festival featuring 150+ renowned authors, poets, and literary organizations. Enjoy live music on five stages, special guest speakers, military veteran writers and comedians, poetry readings, cookbook demos, children's program, and much more.
Admission is free, and attendees will also be able to explore a marketplace of books and food offerings from local vendors.
Not your average book festival! This festival offers something for everyone!
17th Annual Kensington Day of the Book Festival
Sunday, April 21, 2024, 11am-4pm (held rain or shine!)
Howard Avenue, Kensington, MD 20895
www.dayofthebook.com
Instagram: @kensingtonbookfestival
Contact: Elisenda Sola-Sole, Festival Director
301-949-9416 (text preferred)
FEST OF SPRING Caribbean Wine Food & Music Festival
Get ready to experience the vibrant colors, tantalizing flavors, and infectious rhythms of the Caribbean at the FEST OF SPRING Caribbean Wine Food & Music Festival! Hosted by RHU LLC, this exciting festival is set to take place on May 18, 2024, at the picturesque 16700 Barnesville Rd in Boyds, MD.
Step into a world where the Caribbean spirit comes alive! From 12:00 PM onwards, immerse yourself in a sensory journey that celebrates the unique culture, cuisine, and music of the Caribbean. Whether you're an African American, a Reggae or Soca music enthusiast, a wine lover, or part of the vibrant Caribbean diaspora, this festival promises to delight and captivate you in every way.
Let the enticing aromas of mouthwatering Caribbean dishes tantalize your taste buds. Feast on traditional delicacies prepared by expert chefs, showcasing the rich and diverse culinary heritage of the Caribbean. Indulge in flavorful jerk chicken, succulent seafood, and delectable plantain dishes that will transport you straight to the islands.
Accompanying the culinary extravaganza is a carefully curated selection of premium wines, ensuring the perfect pairing for your palate. Sip on fine wines from renowned vineyards, each sip a reflection of the Caribbean's vibrant spirit. Discover new flavors, expand your wine knowledge, and savor unforgettable moments with every glass.
As the sun sets, get ready to groove to the infectious rhythms of Caribbean music. Feel the pulsating beats of reggae, soca, dancehall, and calypso, moving your body to the lively melodies. Live performances by talented musicians and performers will keep the energy high, ensuring a night of unforgettable entertainment.
Don't miss this opportunity to embrace the Caribbean spirit and celebrate the arrival of spring in style! Tickets are available on AllEvents, so secure your spot today. Join us at the FEST OF SPRING Caribbean Wine Food & Music Festival, where cultures collide and unforgettable memories are made.
LIVE PERFORMANCES By: CULTURE Feat. Kenyatta Hill, EXCO LEVI, IMAGE BAND, RAS LIDJ REGG'GO with Special Guest SUGAR BEAR FROM E.U. & MORE! & MORE!
MUSIC By: DJ ABLAZE, DJ SMALLY & NAJ SUPREME
2 NIGHT Camping packages available: RV/CAMPER $200 | TENTS $150 Starting on Friday May 17 @ 5pm | 30 RV SPACES | 30+ TENT SPACES
KIDS 12 & UNDER FREE!!!
