FDA Updates for the Week of March 7, 2022

FDA plans advisory committee for Nuplazid in Alzheimer’s psychosis.

Acadia Pharmaceuticals has resubmitted its supplemental new drug application (sNDA) for Nuplazid (pimavanserin) for the treatment of patients with hallucinations and delusions associated with Alzheimer’s disease psychosis. The resubmission includes additional analyses of two previously conducted studies: HARMONY and Study-019.

The FDA has given the application a target action date of August 4, 2022, and the FDA’s Division of Psychiatry is planning to hold an advisory committee meeting in connection with its review.

The agency had issued a complete response letter in April 2021 for this indication, saying in the HARMONY study there was a lack of statistical significance in some of the subgroups of patients with dementia and a lack of sufficient number of patients in dementia subtypes. Regulatory officials also said that it considered the phase 2 Study-019 not adequate because it was not well controlled and because protocol deviations occurred. No safety issues were raised.

FDA grants approval for another indication for Opdivo.

The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. This approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer. The approval is based on the CheckMate-816 trial, the first positive phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC.

FDA okays a third biosimilar to Neupogen.

The FDA approved the third biosimilar to Amgen’s blockbuster cancer treatment Neupogen (filgrastim). It is used to decrease the incidence of infection after treatment for cancer.

Amneal Pharmaceuticals received the nod for Releuko (filgrastim-ayow), the pharma maker said in a news release. It was developed in collaboration with Kashiv Biosciences.

Releuko will launch in the third quarter of this year and will be manufactured in Chicago. The new biosimilar’s wholesale acquisition cost will be in line with the other Neupogen biosimilars on the market, according to company officials.

Filgrastim is a granulocyte colony-stimulating factor drug used to prevent or treat chemotherapy induced neutropenia (lower-than-normal levels of white blood cells), commonly experienced by patients undergoing chemotherapy.

Sandoz’s Zarxio (filgrastim-sndz), was cleared as FDA’s first ever biosimilar approval in 2015. The second Neupogen biosimilar, Pfizer’s Nivestym (filgrastim-aafi), snagged FDA approval in 2018.

FDA issues complete response letter for long-acting HIV therapy.

Gilead Sciences has received a complete response letter (CRL) for the new drug application (NDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.

In the CRL, the FDA has cited chemistry manufacturing and controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial. In December 2021, the FDA had placed a clinical hold on trials with lenacapavir. The agency had raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution. The concern was about the possibility of glass particles forming in the solution of lenacapavir.

Company officials say they are working with the FDA on a plan for a different vial.

Teva launches first generic to blockbuster cancer med.

Teva Pharmaceuticals has launched lenalidomide, the first generic version of Celgene Corp.’s blockbuster cancer treatment Revlimid (lenalidomide capsules).

Revlimid treats multiple myeloma in combination with dexamethasone (Decadron, other brand names), myelodysplastic syndromes (specifically patients with a deletion of some part of chromosome 5), and mantle cell lymphoma.

Lenalidomide capsules will be available immediately in the United States in 5 mg, 10 mg, 15, mg, and 25 mg strengths.

Additionally, Sandoz recently announced that it has launched a generic of lenalidomide in 19 countries across Europe.

Bayer submits supplemental application for anti-cancer therapy Nubequa.

Bayer has submitted a supplemental new drug application FDA, as well as the submission of a Variation Type II application to the European Medicines Agency for the oral androgen receptor inhibitor Nubequa (darolutamide). Bayer is seeking approval for the use of Nubequa in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer.

The submissions are supported by positive results from the phase 3 ARASENS trial, showing a statistically significant improvement in overall survival for Nubequa plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

FDA grants priority review for Servier’s leukemia application.

Servier has submitted a supplemental new drug application (sNDA) for Tibsovo (ivosidenib) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The sNDA was granted priority review, which accelerates the review and shortens the review time goal from 10 months to six months.

The application is based on the results of the AGILE study, a global, phase 3 trial in patients with previously untreated IDH1-mutated AML. Presented at the 2021 American Society of Hematology Annual Meeting, the data demonstrated that treatment with Tibsovo in combination with azacitidine improved event-free survival. In addition, the combination of showed a statistically significant improvement in overall survival, with a median overall survival of 24 months.

Tibsovo is currently approved in the United States as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia, and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old. The therapy was also recently approved as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma.