SPOTLIGHT -
FDA Approves Byooviz as Interchangeable Lucentis Biosimilar
Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.
Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder
The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
FDA Expands Indication of Voxzogo for Young Children with Dwarfism
Voxzogo is now approved for all ages in children with achondroplasia, the most common form of dwarfism.
Pfizer’s Velsipity Approved for Ulcerative Colitis
Velsipity is the second oral S1P receptor modulator approved by the FDA to treat patients with moderate-to-severe ulcerative colitis. The wholesale acquisition cost is $6,164 for a 30-day supply.
FDA Issues Complete Response for Alvotech’s Biosimilar of Stelara
The regulatory agency found deficiencies in its inspection of Alvotech’s Reykjavik, Iceland, facility. The company plans to resubmit its application once these are addressed.
FDA Approves Braftovi/Mektovi for Non-Small Cell Lung Cancer
The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.
Cosentyx Approved as an IV Formulation
The IV formulation has a wholesale acquisition cost of $2,115 per vial and will be available in the fourth quarter.
Zoryve is Now Approved for Children with Plaque Psoriasis
The dosage of Zoryve for children 6 to 11 is the same as for those over the age of 12. The list price is same for both pediatrics and adults — $825 per tube.
What We’re Reading: the Nobel Prize in Medicine, Striking Healthcare Workers
Coherus Resubmits BLA for Udenyca OnBody for FDA Review
Issues related to finding from an FDA inspection at a third-party filler have been resolved.
Oxycodone on Packaging Line Leads to Recall of Betaxolol
Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.
Manufacturing Issues Lead to CRL for Liquid Botulinum Toxin
Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.
Oncology Drug Exkivity to be Withdrawn from U.S. Market
In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.
FDA Assigns Review Date for Gene Therapy for Rare Immune Disorder
FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.
FDA Approves First Biosimilar of Arthritis Med Actemra
Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.
FDA Issues CRL for Lebrikizumab in Atopic Dermatitis
At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.
FDA Approves New Pompe Therapy
The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.
FDA Sets Review Date for Odronextamab to Treat Blood Cancers
Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
Cross-Contamination Leads to Recall of Two Lots of Brexafemme
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
FDA Approves Drop for Drug-Induced Dilation of the Pupils
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
What We are Reading: A Pioneer in GLP-1 Research Fights for Recognition
Svetlana Mojsov, Ph.D., was a key part of the team that discovered the function of the hormone glucagon-like peptide 1 (GLP-1) and its role in diabetes and weight loss.
Preservative-free Therapy Launches to Reduce Intraocular Pressure in Glaucoma
Iyuzeh can be stored at room temperature. It has a list price of $299 for a month’s supply.
FDA Assigns Review Date for Dupixent in Young Children with Eosinophilic Esophagitis
The FDA has assigned a target action date of Jan. 31, 2024, for Dupixent to treat children 1 to 11 years of age with the inflammatory condition eosinophilic esophagitis.
Potential Contamination Leads to Recall of VistaPharm’s Sucralfate
In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
FDA Issues Complete Response for Udenyca OnBody
The FDA is conducting an ongoing inspection of a third-party filler.
FDA Assigns Review Date for Gene Therapy Atidarsagene Autotemcel
Atidarsagene autotemcel is a one-time gene therapy to treat patients with the rare and fatal disease metachromatic leukodystrophy (MLD). The agency has set a review date of March 18, 2024.
FDA Approves New Dosing Regimen for the H. Pylori Drug Talicia
Earlier this year, RedHill Biopharma began a warranty program for patients taking Talicia, with a commitment to reimburse patient out-of-pocket costs if Talicia does not work.
FDA Approves GSK’s Myelofibrosis Drug
Momelotinib — now with the brand name Ojjaara — is the first treatment for myelofibrosis patients with anemia. It has a list price of $26,900 for a bottle of 30 tablets.
FDA Extends Review for Lifileucel to Treat Melanoma
The date has been extended by three months to Feb. 24, 2024, because of resource constraints at the regulatory agency.