Regulatory

Ohtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years.

In an interview with Pharm Exec Associate Editor Don Tracy, Leonard Mazur, Co-founder, CEO, Citius Pharmaceuticals, offers an update on the recently accepted Biologics License Application for Lymphir by the FDA and other candidates currently in the Citius pipeline.

The Complete Response Letter was issued as a result of inspection findings at a third-party manufacturing facility, unrelated to patritumab deruxtecan’s efficacy or safety in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.

Approval of Epkinly was based on results from the Phase I/II EPCORE trial in patients with relapsed or refractory follicular lymphoma who have already completed two or more lines of systemic therapy.

Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.

Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.

Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older.

Accelerated approval for Krazati is based on results from the Phase 1/2 KRYSTAL-1 study, which demonstrated a 34% objective response rate in patients with previously treated, locally advanced, or metastatic colorectal cancer.

Expansion of Elevidys includes patients over the age of four years with Duchenne muscular dystrophy regardless of their ambulatory status.

Approval of Sofdra marks the first chemical entity to be approved by the FDA to treat primary axillary hyperhidrosis.

Approval of Skyrizi marks the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn disease of similar severity, according to AbbVie.

Approval of Keytruda combination for patients with primary advanced or recurrent endometrial carcinoma is based on results from the NRG-GY018/KEYNOTE-868 clinical trial, which was Phase III trial to evaluate an anti-PD-1 immunotherapy plus chemotherapy combination in patients with two distinct tumor types.

Approval for Capvaxive was based on results from three Phase III trials, which found Capvaxive to be beneficial preventing invasive pneumococcal disease and pneumococcal pneumonia in both vaccine-naïve and vaccine-experienced adults.

The approval of Blincyto was based on results from the Phase III E1910 clinical trial, which found that the treatment significantly improved overall survival in CD19-positive, Ph-negative B-cell ALL compared to chemotherapy alone.

The approval of Imfinzi was based on the DUO-E Phase III trial, which indicated that in combination with chemotherapy, the drug reduced the risk of disease progression or death by 58% in mismatch repair deficient endometrial cancer.

Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.

AstraZeneca’s Farxiga has previously been approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, in addition to indications for heart failure.

The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample.

Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics.

Klisyri is now available in a 350 mg package size as a topical treatment for actinic keratosis on the face or scalp.

Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease.

Approval of Rytelo could provide patients with lower-risk myelodysplastic syndromes with extended periods without the need for red blood cell transfusions to alleviate symptomatic anemia.

According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.

A similar application was also submitted to the EMA for the expanded use of Prezcobix to treat children aged 6 years and older with HIV.

In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder.

EVERSANA INTOUCH Media’s EVP discusses how the ban may impact the industry and how companies can prepare for it.

Approval of Onyda XR marks the first liquid non-stimulant medication for attention-deficit hyperactivity disorder to hit the market in the United States.

Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.

Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer.

Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma.