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New Drugs Approved In October

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Four new drugs were approved by the FDA in the month of October. This compares with 11 drugs approved by the regulator last year.

Inmazeb

The FDA approved Inmazeb, developed by Regeneron Pharmaceuticals, Inc. (REGN), on October 14, 2020 for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

Inmazeb is a cocktail of three monoclonal antibodies, atoltivimab, maftivimab and odesivimab, developed using Regeneron's VelocImmune platform.

Inmazeb is the first treatment approved by the FDA specifically for Ebola.

As per the agreement signed in July this year, Regeneron will deliver an established number of Inmazeb treatment doses over the course of six years to the Biomedical Advanced Research and Development Authority (BARDA), as part of the U.S. Department of Health and Human Services' (HHS) goal of building national preparedness for public health emergencies.

Veklury

The FDA greenlighted Veklury, developed by Gilead Sciences, Inc. (GILD) on October 22, 2020 for the treatment of patients with COVID-19 requiring hospitalization. The drug is indicated for patients of age 12 years and older and weighing at least 40 kg.

Veklury, known generically as Remdesivir, works by stopping the replication of SARS-CoV-2, the virus that causes COVID-19.

The drug's label carries warning about the risks of hypersensitivity, including infusion-related and anaphylactic reactions, increased risk of transaminase elevations, and the risk of reduced antiviral activity when co-administered with chloroquine or hydroxychloroquine.

Veklury has been approved or authorized for the treatment of Covid-19 in about 50 countries across the world.

Eysuvis

Developed by Kala Pharmaceuticals, Inc. (KALA), Eysuvis (loteprednol etabonate) was given thumbs-up by the FDA on October 26, 2020, for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface, and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage.

Eysuvis is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease.

Kala plans to launch the product by the year-end.

Bronchitol

The FDA granted approval to Bronchitol (mannitol), Inc. on October 30, 2020.

Bronchitol (mannitol), a sugar alcohol, is indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older.

Bronchitol, developed by Pharmaxis Ltd., and distributed exclusively by privately-held Chiesi USA, Inc., is the first and only inhaled dry powder approved for this indication.

Chiesi plans to launch Bronchitol in the U.S. in March, 2021.

Bronchitol is currently marketed in more than 10 countries including Australia, Italy, Germany, and Russia.

The drug can cause serious side effects, including sudden breathing problems, and hemoptysis.

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