Post Buying Request
Home > Industry News > Givlaari Approved for Acute Hepatic Porphyria

Givlaari Approved for Acute Hepatic Porphyria

Givlaari Approved for Acute Hepatic Porphyria2019.11.25

On Wednesday, the U.S. Food and Drug Administration announced the approval of Givlaari (givosiran) for the treatment of acute hepatic porphyria.

Previous treatment options for this genetic disorder have only provided partial relief from the pain of porphyria attacks, according to Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research. Givlaari helps to reduce the number of attacks. The recommended dose of Givlaari is a subcutaneous injection of 2.5 mg/kg once monthly.

FDA APPROVAL

Approval of Givlaari was based on clinical data from 94 patients with acute hepatic porphyria. Compared with patients who received placebo, patients who received Givlaari had 70 percent fewer porphyria attacks that required hospitalization, urgent health care visits, or home intravenous infusion of hemin.

Commonly reported side effects of Givlaari include nausea and injection site reactions. Clinicians should monitor patients for anaphylactic reaction and renal function, and patients should have their liver function tested before and during treatment.

Approval was granted to Alnylam Pharmaceuticals.

Source: drugs.com

Find pharmaceutical raw materials on OKCHEM (click to inquire)

Related news in the pharmaceutical industry
The newly revised Drug Administration Law of China to take effect on December 1, 2019 for better regulation of drug production
Industry of Vitamin A: Supply Decrease and Market Demand Increase in Short Term
Export of China's nutrition and health products in the first half of 2019
FDA: Biotin Supplements Could Affect Results of Medical Tests
CPhI Annual Report predicts Europe to surpass the USA in biologic manufacturing capacity by 2023
FDA approves first therapy to treat patients with rare blood disorder
Protein could offer therapeutic target for pancreatic cancer
2019 China Vitamin C Export, Market Structure and Prospect Introduction

Tag
Share It : Givlaari Approved for Acute Hepatic Porphyria Givlaari Approved for Acute Hepatic Porphyria Givlaari Approved for Acute Hepatic Porphyria Givlaari Approved for Acute Hepatic Porphyria