- Drug Coverage
- Hypertrophic Cardiomyopathy (HCM)
- Vaccines: 2023 Year in Review
- Eyecare
- Urothelial Carcinoma
- Women's Health
- Hemophilia
- Heart Failure
- Vaccines
- Neonatal Care
- NSCLC
- Type II Inflammation
- Substance Use Disorder
- Gene Therapy
- Lung Cancer
- Spinal Muscular Atrophy
- HIV
- Post-Acute Care
- Liver Disease
- Pulmonary Arterial Hypertension
- Safety & Recalls
- Biologics
- Asthma
- Atrial Fibrillation
- Type I Diabetes
- RSV
- COVID-19
- Cardiovascular Diseases
- Breast Cancer
- Prescription Digital Therapeutics
- Reproductive Health
- The Improving Patient Access Podcast
- Blood Cancer
- Ulcerative Colitis
- Respiratory Conditions
- Multiple Sclerosis
- Digital Health
- Population Health
- Sleep Disorders
- Biosimilars
- Plaque Psoriasis
- Leukemia and Lymphoma
- Oncology
- Pediatrics
- Urology
- Obstetrics-Gynecology & Women's Health
- Opioids
- Solid Tumors
- Autoimmune Diseases
- Dermatology
- Diabetes
- Mental Health
Novartis Resubmits Application for Inclisiran
The company is transferring manufacturing of the final product to its own site in Austria.
Novartis has announced it has resubmitted its New Drug Application for inclisiran to treat hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C).
In December 2020, the FDA issued a Complete Response Letter for inclisiran because of issues related to a third-party manufacturing facility. In its resubmission, Novartis indicated that it is listing its own site in Schaftenau, Austria, as the manufacturing location for the finished product. Novartis indicated that the transfer of the manufacturing of inclisiran to Austria was planned and initiated in 2020, prior to the receipt of the CRL.
The FDA did not raise any concerns related to the efficacy or safety of inclisiran.
Inclisiran is a small interfering RNA (siRNA) therapy to reduce low-density lipoprotein cholesterol levels via an RNA interference mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease. It works by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C and clearing it from the bloodstream. With two doses a year and effective and sustained LDL-C reduction, inclisiran works as a complement to statins.
The European Commission granted Novartis marketing authorization for Leqvio (inclisiran) in Europe on December 11, 2020.
Novartis had obtained rights to inclisiran from Alnylam Pharmaceuticals.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More
