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Perspective on the Rx Pipeline

August 27, 2019

News on development of the first oral GLP-1 Receptor Agonist for type 2 diabetes and more

EnvisionRx continuously monitors the drug pipeline. Our team evaluates changing treatment options in order to educate and inform our clients on the most impactful medications in development, new drugs recently approved, generics being launched and current medications receiving new indications.

Clinical Pipeline

Within the extensive pipeline of drugs preparing for market launch, these are the three most notable drugs plan sponsors should be aware of:

  • Golodirsen is a gene-editing IV infusion therapy that targets the exon 53 gene in patients with Duchenne muscular dystrophy to develop shorter, yet functional dystrophin proteins. 
  • Semaglutide, if approved, would be the first oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) available to provide glucose-lowering effects and other benefits to patients with type 2 diabetes.
  • Ubrogepant will be the first oral option for the new class of calcitonin gene-related peptide (CGRP) inhibitors used as abortive treatment for migraines 

Drug Approvals

Five drugs recently approved by the Food and Drug Administration (FDA) include:

  • Dengvaxia® (dengue tetravalent vaccine, live), the first vaccination to prevent subsequent dengue disease in patients nine to 16 years of age with a history of the disease and living in an endemic area. 
  • Piqray® (alpelisib) an oral therapy for the treatment of both men and postmenopausal women with HR(+), HER2(-) breast cancer and the PIK3CA gene.
  • Vyleesi™ (bremelanotide acetate) a self-injection treatment for hypoactive sexual desire disorder in premenopausal women who are not experiencing symptoms due to other conditions, medications or relationship issues.
  • Vyndaqel®/Vyndamax® (tafamidis meglumine/tafamidis) oral medications used to reduce cardiovascular hospitalizations and deaths in patients with wild type and hereditary transthyretin-mediated amyloidosis.
  • Zolgensma® (onasemnogene abeparovec-xioi) a gene-therapy biologic for the treatment of spinal muscular atrophy in patients under two years of age.

The full report also includes a table on biosimilars that have received approval.

New Indications

Drugs that have gained FDA approval for the treatment of additional diseases and/or conditions and have potential to be impactful include:

  • Benlysta® (belimumab) for patients with active, antibody systemic lupus erythematosus was expanded from an indication for the treatment of adults to include patients five years of age and older.
  • Doptelet® (avatrombopag) was expanded to treat chronic immune thrombocytopenia (ITP) in adults with chronic liver disease who have not responded to previous treatments.
  • Dupixent® (dupilumab) in addition to treatments for uncontrolled atopic dermatitis and asthma, the indication was expanded to treat adults with chronic rhinosinusitis with nasal polyps.
  • Emgality® (galcanezumab-gnlm) was approved to treat episodic cluster headaches.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for pain, chemotherapy-induced vomiting and the treatment of ulcerative colitis. A review of generic launches is included in the full report.

Download the full report for more information, including important safety updates and drug shortages and discontinuations.