Perspective on the Rx Pipeline: News on the approval of a vaccine for the bird flu 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:

• KTE-X19, a potential treatment for mantle cell lymphoma, a rare and often fatal B-cell malignancy belonging to the non-Hodgkin lymphoma group. If approved, the drug may hold more promising results for the treatment of the disease and advancement of CAR-T therapy.
• Valrox, a gene therapy for the treatment of hemophilia A that offers promising efficacy and safety data. If approved, it would be the first gene therapy treatment for hemophilia.
• Viloxazine hydrochloride, a non-stimulant serotonin norepinephrine modulating agent for the treatment of attention deficit hyperactivity disorder (ADHD). If approved, it would be the first non-stimulant to treat ADHD in a decade that works differently than available treatment options.

Drug Approvals

Six drugs recently approved by the FDA include:

• Audenz™ (influenza A [H5N1] monovalent vaccine, adjuvanted), a vaccine for H5N1, also known as the "bird flu."
• Isturisa® (osilodrostat), a non-surgical treatment option for Cushing's disease.
• Koselugo™ (selumetinib), the first FDA-approved phamacological treatment for neurofibromatosis type 1 (NF1) with inoperable plexiform neurofibromas (PN), a lifelong and sometimes fatal pediatric disease.
• Oriahnn™ (elagolix, estradiol, norethindrone acetate), a combination therapy for the management of heavy menstrual bleeding caused by uterine fibroids that can be used for up to 24 months.
• Pizensy™ (lactilol monohydrate), a new hyperosmotic agent for the treatment of idiopathic constipation.
• Tukysa™ (tucatinib), approved for the treatment of advanced HER2-positive breast cancer, including those with brain metastases who have received one or more prior HER2-based regimens.

New Indications

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

• Brilinta® (ticagrelor), now indicated to reduce the risk of a first myocardial infarction or stroke in patients with coronary artery disease.
• Dupixent® (dupilumab), expanded to treat patients aged six and older with moderate-to-severe atopic dermatitis.
• Eucrisa® (crisaborole), indicated as a topical treatment for mild-to-moderate atopic dermatitis in adult and pediatric patients three month of age and older.
• Farxiga® (dapagliflozin), approved for the new indication to reduce the risk of cardiovascular death and hospitalization due to heart failure.
• Lynparza® (olaparib), received two new indications. One as a maintenance treatment for homologous recombination deficiency advanced ovarian cancer, and another for the treatment of somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer.
• Ofev® (nintedanib), approved for the treatment of chronic fibrosing interstital lung diseases with progressive phenotype.
• Reblozyl® (luspatercept-aamt), received a new indication for the treatment of adult patients with anemia associated with myelodysplastic snydromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with sideroblasts and thrombocytosis.
• Taltz® (iekizumab), had two indication updates, an expansion of its psoriasis indication to allow for treatment in those six years of age and older, and approval for treatment of adults with active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for the treatment of ADHD, cancer and HIV. A review of generic launches, including biosimilars, is provided in the full report.

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