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New Drugs Approved In The Month Of March

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The novel coronavirus that originated in the city of Wuhan in China last December, has spread to almost all the countries, affecting millions. As of this writing, the number of confirmed cases is 1,274,346 and the death toll is 69,480.

Almost all international airports have been closed around the world and many countries are enforcing lock downs among its nationals to reduce the spread of the virus. The situation is impacting almost all fields with pharmaceutical industry facing its own share of problems. Clinical trial enrollments are staggering due to lock down and regulatory approvals are getting delayed.

In March, only four drugs were approved by the FDA. Let us take a look at the new drugs that were approved.

Sarclisa

The FDA approved Sarclisa (isatuximab-irfc),developed by Sanofi (SNY) on March 2, 2020.

Sarclisa, a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells, is approved to be used in combination with Bristol-Myers Squibb's pomalidomide and steroid dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

The wholesale acquisition cost for Sarclisa is $650 per 100 mg vial and $3,250 per 500 mg vial.

Rival drug, Johnson and Johnson's Darzalex (daratumumab) had sales of $830 million in the fourth quarter of 2019.

Last week, Sanofi received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Sarclisa.

Durysta

The FDA approved Durysta (bimatoprost), developed by Allergan plc (AGN) on March 3, 2020 to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Durysta is an ophthalmic drug delivery system that is implanted into the anterior chamber of the eye. It is the first intracameral, biodegradable sustained-release implant for the indication.

Allergan, in June, had announced that it was being acquired by AbbVie Inc.(ABBV) for approximately $63 billion, cash and stock. The deal is expected to close early this year.

Isturisa

The FDA approved Isturisa (osilodrostat), developed by Novartis AG (NVS), on March 6, 2020 for the treatment of patients with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease.

Cushing disease is caused by a pituitary tumor that releases too much of a hormone called adrenocorticotropin, which stimulates the adrenal gland to produce an excessive amount of cortisol. This disease can cause significant health issues, such as high blood pressure, obesity, type 2 diabetes, blood clots in the legs and lungs, bone loss and fractures, a weakened immune system and depression.

Isturisa is the first FDA-approved drug to directly address this cortisol overproduction by blocking the enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis.

The most common side effects included adrenal insufficiency, nausea, fatigue and oedema.

The drug is expected to be launched in the second or third quarter.

Zeposia

The FDA approved Zeposia (ozanimod), developed by Bristol-Myers Squibb Company (BMY), on March 25, 2020 for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Multiple sclerosis (MS) is an autoimmune disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell causing a wide range of symptoms throughout the body.

Analysts expect the drug to bring in sales of $1.6 billion in 2024. Zeposia will have to compete with Novartis' Gilenya, which had $3.22 billion in sales in 2019.

Last week, Zeposia had received positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Bristol-Myers plans to delay the launch of the drug due to COVID-19 pandemic.

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