Denise Myshko

A meta-analysis has found that depression and anxiety are significantly correlated with dry eye disease symptoms but not to dry eye disease signs.

The FDA has made several approvals this week, including Enhertu for HER2-low breast cancer, a steroid-free cream for plaque psoriasis and the first interchangeable biosimilar to Lucentis, as well as Stelara in children with psoriatic arthritis. The agency has issued a complete response letter for Nuplazid in Alzheimer’s psychosis. Regulators have accepted a BLA for a biosimilar of Actemra and scheduled a second advisory committee meeting for AMX0035 in ALS.

A literature review finds that glaucoma care changed for the better during the COVID-19 pandemic.

Vabysmo is the first injectable bispecific antibody to treat wet age-related macular degeneration and diabetic macular edema. Some recent data suggests that the injections can be administered less often than first indicated with no loss of efficacy.

A small study finds that an adeno-associated virus gene therapy eliminated both spontaneous bleeding and the need for factor IX prophylaxis in patients with hemophilia B.

The FDA has approved lupus therapy for children and allows importation of contrast medium. The agency has accepted applications for several therapies, including for a Tysabri biosimilar, a therapy for a genetic form of ALS, and an immunotherapy for bladder cancer, as well as for Enhertu in low HER2 breast cancer. Additionally, AbbVie seeks additional indication for Rinvoq.

FDA approves Xalkori for rare tumor, as well as Opzelura for skin conditions. The agency has accepted applications for a supplemental indication for the biosimilar Hyrimoz and pegcetacoplan for advanced macular degeneration. Additionally, Acadia submits NDA for trofinetide.

In COVID-19 news, the FDA grants EUA for Novavax’s COVID-19 vaccine. The agency approved a novel diagnostic dye and another indication for Xalkori, but delayed a decision on a therapy for esophageal cancer. FDA has also accepted a BLA for advanced HER2 breast cancer therapy. Finally, Can-Fite BioPharma plans submission for psoriasis therapy.

As Congress considers legislation that would cap out-of-pocket costs for insulin, Walmart and Civica Rx are taking steps that could make less expensive versions of the diabetes medication more available.

Those with age-related macular degeneration like the port delivery system for ranibizumab because it requires fewer treatments and there is less discomfort.

The FDA expands label for Krystexxa. Agency has granted priority review for two therapies: lecanemab for Alzheimer’s disease and a novel immunotherapy for follicular lymphoma. The FDA will convene a second advisory committee for ALS therapy. Additionally, Bausch + Lomb submits NDA for dry eye disease therapy.

Reproxalap is a potential new therapy for dry eye disease with a novel mechanism of action.

In a study, both common and rare HMGCR variants were associated with an increased risk for cataract.

In COVID-19 news, the FDA has declined an EUA request for Zyesami and Pfizer has submitted NDA for Pavlovid. The regulatory agency has accepted several applications, including an sBLA for Eylea in diabetic retinopathy and the NDA for palovarotene for a rare genetic disorder. The FDA also issued a CRL for a UTI therapy and extended the review of diabetes therapy. And finally, Gilead has resubmitted its twice-year HIV therapy.

FDA approves tumor-agnostic cancer therapy, Clovis pulls Rubraca indication, Purdue launches opioid reversal, FDA plans advisory committee meeting for Xphozah, and Manarini and AbbVie submit applications.

In COVID-19 news, the FDA expanded emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age. The FDA also approved Skyrizi for Crohn’s disease, Olumiant for alopecia, as well as two rare disease therapies: Imcivree for obesity associated BBS and Amvuttra for neuropathy associated with rare disease. Additionally, FDA extended the PDUFA date Brukinsa.

Dogged by controversy, the new Alzheimer’s drug has not fared well since its approval by the FDA a year ago.

In COVID-19 news, an FDA advisory committee recommends EUA for Novavax’s vaccine. The FDA has also granted approvals to Dupixent for children as young as 6 month with atopic dermatitis and to the biosimilar Riabni for rheumatoid arthritis. An advisory committee has also recommended approval for two gene therapies, one for a rare neurogenerative disease and another for a blood disease.

A biomarker used in kidney disease screening has potential to identify people with sight-threatening diabetic retinopathy.

Perfluorohexyloctane prevents excessive tear evaporation and has the ability to restores tear film balance. A new drug application is expected to be filed this year.

The FDA has withdrawn the approval of Ukoniq, which is used to treat two specific types of lymphoma. In approvals, the regulatory agency has approved a new indication for Kymriah, two addition Opdivo regimens, and extended the use of Evrysdi in newborns with SMA. The agency also accepted for review Dupixent to treat skin lesions but extended the review of a new ALS therapy, refused to file an application for a rare metabolic disorder, and put a hold on the trial for Cialis OTC.

If approved, Orasis’ low-dose pilocarpine would be the second product that improves presbyopia, which is the age-related loss of clear up-close vision. The company plans to submit an NDA in the second half of the year.

The FDA has approved the first non-steroid cream for psoriasis, as well as another biosimilar of Neulasta, Tibsovo combination for older patients with leukemia and a new formulation of Tyvaso. The agency has issued a second CRL for poxvirus treatment and also accepted applications for several therapies, including a nasal spray for migraine, mirvetuximab for ovarian cancer, and a treatment for the rare disease Friedreich’s ataxia.

In COVID-19 news, FDA expanded EUA for Pfizer/BioNTech COVID-19 booster to children 5 to 11 years and cleared first at-home combo COVID-19, RSV and flu test, but declined an EUA for the antidepressant fluvoxamine to treat COVID-19. Regulators also approved Lilly’s novel diabetes drug and Dupixent eosinophilic esophagitis, modified Dsuvia REMS program and issued a CRL for bimekizumab for psoriasis.

In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.

The administration of adult stem cells increased survival in patients with both acute and chronic graft-versus-host disease in a compassionate use program.

The FDA has approved a rare disease therapy and an additional indication for Enhertu, and grants priority review for Imfinzi in biliary tract cancer. Regulators have issued complete response letters for three therapies. The agency also has scheduled an advisory committee for Nuplazid in Alzheimer’s psychosis.

The Build Back Better legislation would have had far-reaching effects on Medicare Parts B and D but the legislation has stalled, and it is unclear if any significant federal legislation affecting specialty pharamcy will pass this year. Meanwhile, several states are addressing white bagging, according to Tracy Russell of CoverMyMeds.

It’s been a busy week at the FDA. The agency has approved mavacamten for hypertrophic cardiomyopathy, an oral therapy for yeast infections, an additional indication for Ultomiris, Rinvoq and Veklury. Additionally, Moderna seek EUA for vaccine for young children and the FDA will hold an advisory committee meeting for both Xphozah in kidney disease and Novavax’s COVID-19 vaccine.

The FDA has approved a generic of Zavesca for Gaucher disease and has accepted applications for a supplement indication for Enhertu and a novel therapy for CKD-related anemia. The regulatory agency also issued a CRL for Teva’s schizophrenia drug.