Galien week of innovation

Product: XPHOZAH® 

Company: Ardelyx, Inc.

About the Product:

XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily.

Product: LEQEMBI® 

Company: Eisai Inc. and Biogen Inc. 

About the Product:

LEQEMBI is the first traditionally approved treatment shown to reduce the rate of disease progression and to slow cognitive functional decline in adults with early Alzheimer’s disease. LEQEMBI represents a significant milestone for the Alzheimer’s community, including patients and families affected by this progressive, devastating disease.

Product: Sunlenca®

Company: Gilead Sciences, Inc.

About the Product:

Sunlenca® (lenacapavir) is a first-of-its-kind capsid inhibitor that offers a new option to help adults with multi-drug-resistant HIV achieve and maintain viral suppression. Its unique mode of action, picomolar potency, and long half-life allow dosing once every six months, representing a significant breakthrough for heavily treatment-experienced individuals with multi-drug-resistant HIV. Beyond the immediate impact for this population, the distinctive properties of lenacapavir lay the groundwork for a new era of long-acting, person-centric HIV treatment and prevention options. Lenacapavir is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment and prevention that could uniquely fit into the lives of people with HIV and individuals who may benefit from pre-exposure prophylaxis (PrEP).

Product: Johnson & Johnson

Company: RYBREVANT® (amivantamab-vmjw)

About the Product:

RYBREVANT® (amivantamab-vmjw) COMPANY: Johnson & Johnson Product Description: RYBREVANT is a fully-human bispecific antibody used alone or in combination with other medications to treat adults with advanced non-small cell lung cancer (NSCLC) having specific genetic alterations as detected by an FDA-approved test. By binding to two different receptors and providing immune cell-directing activity, RYBREVANT has broadened the scope of patients for whom targeted therapy is available and effective.

Product: LIVMARLI®

Company: Mirum Pharmaceuticals

About the Product:

LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the FDA for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older and is the only FDA-approved medication to treat this indication. LIVMARLI is currently being evaluated in late-stage clinical studies in other rare liver diseases including PFIC and biliary atresia. LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS, PFIC and biliary atresia.

Product: WINREVAIR™ 

Company: Merck & Co. Inc.

About the Product:

WINREVAIR is Merck’s approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

Product: Pluvicto  

Company: Novartis

About the Product:

Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapy (RLT) approved in the US and EU for a type of advanced prostate cancer. RLTs are medicines that combine the precision of targeted therapies with the power of radioactive medicine. A targeting compound, or ligand, links with a radioactive isotope to deliver radiation therapy directly to cancer cells, with the goal of limiting impact on nearby healthy cells. Novartis is pioneering the development of multiple assets on the RLT platform, with the aim of bringing potential new treatment options for various types of cancer.

Product: CIBINQO^TM

Company: Pfizer Inc.

About the Product:

CIBINQO® Atopic dermatitis (AD) is one of the most common inflammatory skin diseases, affecting people of all ages and genders. CIBINQO™ offers hope to millions of patients 12 years of age and older with moderate to severe eczema who are suffering daily with this immuno-inflammatory condition that can cause intense and persistent itching and skin rash. CIBINQO™ is an oral Janus Kinase inhibitor that targets JAK1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in AD pathophysiology, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). The clinical relevance specific JAK inhibition is not known.

Product: PAXLOVID^TM

Company: Pfizer Inc.

About the Product:

PAXLOVID™ PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) is a 5-day oral prescription medicine that is FDA-approved to treat mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID, an antiviral, stops the SARS-CoV-2 virus from multiplying and reduces the amount of it in your body. Nirmatrelvir blocks the activity of the Mpro, which the coronavirus needs to replicate. Co-administration with ritonavir helps slow the metabolism of nirmatrelvir for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

Product: VOQUEZNA

Company: Phathom Pharmaceuticals

About the Product:

VOQUEZNA (vonoprazan) is a novel first-in-class potassium-competitive acid blocker (PCAB) for treatment of gastroesophageal reflux disease (GERD) and H. pylori with proven efficacy, a safety profile comparable to a proton pump inhibitor (PPI), and an innovative mechanism of action that provides rapid, potent, and durable acid suppression. VOQUEZNA demonstrated key efficacy advantages relative to a PPI across multiple endpoints shown in pivotal Phase 3 trials. The U.S. FDA approval of VOQUEZNA marked the first major innovation for the treatment of GERD in over 30 years. This novel innovation has the potential to change the GERD treatment paradigm.