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Drugs to watch 2018
12 new drugs are forecast to enter the market in 2018 and achieve blockbuster sales of USD1 billion or more by 2022

As the drug-pricing debate continues in the U.S., 2017 saw a record of 46 new drug approvals by the Food and Drug Administration (FDA), the highest total in more than two decades. Of these approved drugs, 17 (37 per cent) were approved with Breakthrough Therapy designation, a designation created in 2012 to accelerate the development of products that showed substantial improvement over existing therapies for serious and life-threatening diseases.

The approval of cancer immunotherapies—Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) chimeric antigen receptor T cell (CAR-T) therapies—grabbed headlines in 2017 because of their ability to revolutionize the treatment of the disease. These therapies, a form of gene therapy, represent a major breakthrough for the development of personalized medicine and lay the groundwork for further advances in this field.

More than half of the drugs in 2018 have been granted Priority Review, Breakthrough Therapy or Fast Track designations. Five drugs on the list are first-in-class and four are for orphan diseases.

In stark contrast to 2017, where more than half of the drugs on the blockbuster list were cancer treatments, only one blockbuster expected to launch in 2018 is for cancer (Erleada [apalutamide]).

Despite political and regulatory uncertainties in the U.S. and EU markets, the pace of pharmaceutical innovation continues to accelerate. 2018 is on track to see many new and potentially game-changing drugs come to market, benefiting the lives of millions of patients around the world.

A few additional therapies could enter the market in 2018 that are worth watching, especially if they receive accelerated approval.

Juno Therapeutics’ CAR T-cell therapy, lisocabtagene maraleucel, is expected to be filed for diffuse large B-cell lymphoma in the second half of 2018 and has 2022 sales forecasts of USD2.221 billion.

Alexion’s next-generation Soliris treatment, ravulizumab, for paroxysmal nocturnal hemoglobinuria, is expected to file for approval in the third quarter of 2018. This drug is forecast to generate USD2.199 billion of sales by 2022.

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