Formulary Watch |

Survey: ICER Assessments Impact Payer Decision-Making

BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder

Reblozyl was being reviewed to treat anemia in adults with non-transfusion dependent beta thalassemia, an inherited blood disorder. BMS indicated it couldn’t appropriately address FDA’s questions about risk-benefit.

New Generic Launches

New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.

FDA Extends Review of ALS Therapy

BMS Updates Vidaza Label After Pediatric Indication Approval

FDA Issues Refusal to File Letter for Pegzilarginase

The FDA is asking for additional data to support effectiveness of pegzilarginase to treat a rare metabolic disease. If approved, pegzilarginase would be the first treatment for ARG1 deficiency.

IQVIA Finds New Cancer Clinical Trials are Increasing

Biogen/Samsung Bioepis Launch the Biosimilar Byooviz

Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.

FDA Puts Hold on Trial for Cialis OTC

The regulatory agency indicated there is an issue surrounding the protocol design.

FDA Accepts Dupixent Application for Treating Skin Lesions

If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.

FDA Withdraws Approval of Ukoniq

Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions

In high-deductible plans, patients had the highest out-of-pockets costs and abandoned and discontinued therapy at greater rates than other benefit designs.

FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA

Evrysdi is now approved to treat spinal muscular atrophy in children and adults of all ages.

FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers.

Bipartisan Bill Aims to Require Transparency Among PBMs

FDA Approves Kymriah for Adults with Follicular Lymphoma

Kymriah is now approved in three indications and is the only CAR-T cell therapy approved in both adult and pediatric settings.

New Global Coalition Aims to Improve Access to Cancer Medicines

FDA Approves Amneal’s Biosimilar of Neulasta

This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.

FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia

The FDA has assigned a Prescription Drug User Fee Act target action date of Nov. 30, 2022. Regulators indicated they plan to hold an advisory committee meeting to discuss the application.

FDA Approves Tibsovo Combination for Older Patients with Leukemia

Tibsovo is the first therapy targeting cancer metabolism for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.

FDA Issues Second CRL for Poxvirus Treatment

Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.

FDA Accepts BLA for Hemophilia B Gene Therapy

If approved, etranacogene dezaparvovec would be the first gene therapy for patients with hemophilia B. An FDA decision is expected in November 2022.

Shining Light on the Barriers Payers Place on Medications

Teva Recalls One Lot of Anagrelide

The impacted lot failed a dissolution test, meaning it was taking longer to dissolve once ingested. This can result in less anagrelide available in the body, possibly leading to clotting or bleeding events such as a heart attack or stroke.

FDA Approves First Non-Steroid Cream for Psoriasis

Vtama is approved to treat adults with mild, moderate, and severe psoriasis. It is expected to be available in the first week of June 2022.

FDA Approves New Formulation of Tyvaso

Tyvaso DPI is a dry inhalation powder and new inhalation device to treat patients with pulmonary arterial hypertension, a life-threatening disease. It is expected to be available in June 2022.

COVID-19’s Impact on Teenagers’ Mental Health

Prime Therapeutics’ Biosimilar Program Cut Expenses by 26%

FDA Accepts NDA for Nasal Migraine Treatment

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the first quarter of 2023 for zavegepant, a nasal spray for the acute treatment of patients with migraine.

FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.