Business Corpus: Cannabis, Migraines, Gene-Silencing: FDA Approvals Hit High Note In 2018The Food and Drug Administration approved 59 new drugs in 2018 — hitting at least a four-year record — though fewer biologic drugs passed muster. There were also 17 biologic drugs approved. The post Cannabis, Migraines, Gene-Silencing: FDA Approvals Hit High Note In 2018 appeared first on Investor's Business Daily.

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The Food and Drug Administration approved 59 new drugs in 2018 — hitting at least a four-year record — though fewer biologic drugs passed muster.

In total, the FDA approved 59 new molecular entities, or NMEs, essentially pharmaceutical products that use chemical ingredients. U.S. regulators also approved 17 biological license applications, or BLAs, from companies that use biologic materials within their drugs.

NME approvals rose more than 28% year over year, while BLA approvals dipped nearly 23%.

New Drugs In 2018 Hit Record

Several of the new drugs were also new modes of treating disease. Noteworthy on the list are Onpattro from Alnylam Pharmaceuticals (ALNY), and Tegsedi from Ionis Pharmaceuticals (IONS) and Akcea Therapeutics (AKCA). Both are gene-silencing drugs.

Others include the first approval of a cannabis-based drug called Epidiolex. Epidiolex, from GW Pharmaceuticals (GWPH), can treat two forms of epilepsy appearing in childhood.

The FDA also gave the nod to three new drugs that aim to prevent migraines via a substance in the body called CGRP. These include drugs from Amgen (AMGN), Teva Pharmaceutical (TEVA) and Eli Lilly (LLY). Alder Biopharmaceuticals (ALDR) is expected to follow suit.

Vertex Pharmaceuticals (VRTX) also added a new cystic fibrosis regimen called Symdeko. Symdeko is a combination of two other medicines known as tezacaftor and ivacaftor. Ivacaftor is also sold independently under the brand name Kalydeco.

On the biologic side, Portola Pharmaceuticals (PTLA) had its second approval with an anticoagulant called Andexxa. In general, fewer biologics grab approvals in a given year due to complexity and the length of time it takes to complete clinical testing.

Cancer Treatments A Huge Area Of Focus

Oncology proved a big theme for 2018 with 17 new cancer treatments getting approval. The FDA also approved a drug to prevent nausea and vomiting associated with some forms of chemotherapy.

Of the cancer treatments, Loxo Oncology (LOXO) and Bayer's (BAYRY) Vitrakvi is unique. It treats cancers tied to a specific genetic mutation and belongs to a class of precision medicine drugs. Analysts also expect Blueprint Medicines (BPMC) and Deciphera (DCPH) to grab approval for similar drugs.

Array Biopharma (ARRY) grabbed two approvals for melanoma treatments in June. Blood cancers also proved an area of interest with six approvals in leukemia treatment. Two companies also grabbed approvals in lung cancer treatment, and another had a breast cancer drug.

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The post Cannabis, Migraines, Gene-Silencing: FDA Approvals Hit High Note In 2018 appeared first on Investor's Business Daily.