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Will These Drugs Reach Blockbuster Status?


The journey of drugs from bench to bedside is a roller coaster ride. It is estimated that only 5 in 5,000 compounds that enter preclinical testing make it to human testing, and out of those 5, only 1 may pass through all the regulatory hurdles needed to reach pharmacy shelves.

But unless there is market acceptance, just getting approval won't guarantee success even if the drug is safe and effective.

In 2017, 46 novel drugs were approved by the FDA. Of the 46 novel drugs, 6 were granted accelerated approval, i.e., by relying on surrogate endpoints, and 18 were indicated for rare or "orphan" diseases.

Overall, in terms of approvals, 2017 was a year of innovation and advances.

Endari, the first new treatment for patients with sickle cell disease in almost 20 years, Genentech's Hemlibra, the first-ever non-blood product to treat patients with hemophilia A with inhibitors, Actemra, the first treatment for adults diagnosed with giant cell arteritis, BioMarin's Brineura, the first treatment for a form of Batten disease, Benznidazole, the first U.S. treatment for Chagas disease, Novartis' Kymriah to treat certain children and young adults with B-cell acute lymphoblastic leukemia, which is also the first gene therapy to become available in the United States, are some of the drugs that received the FDA's stamp of approval in 2017.

Clarivate Analytics, a provider of insights and analytics for research and innovation, has predicted blockbuster status for 12 drugs. The drugs include the recently approved ones and those that are currently under FDA review. Clarivate used Cortellis database to forecast the sales of the drugs.

Here's the list of potential blockbusters

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