Biotech Stocks Facing FDA Decision In October

(RTTNews) - As we head into another month of new drug approvals, it's time to take a look at some of the FDA-related news that grabbed headlines in September.

Seeking to curb the sharp rise in the number of teens using e-cigarettes, the FDA, has expanded its Youth Tobacco Prevention Plan, which was first introduced last April.

The expanded plan, known by the name "The Real Cost" Youth E-Cigarette Prevention Campaign, a foundational component of the Youth Tobacco Prevention Plan, particularly in educating youth about the dangers of vaping, was launched on September 18.

The month also saw the U.S. regulatory agency taking new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). The REMS program now requires, for the first time, that training be made available to health care providers who are involved in the management of patients with pain, and not only to prescribers. This modified Opioid Analgesic REMs covers 347 opioid analgesics compared to 62 products covered under the previous REMS program.

On September 13, a new leukemia drug, Lumoxiti, developed by AstraZeneca, was greenlighted by the FDA for the treatment of adult patients with relapsed or refractory hairy cell leukemia. This drug is expected to achieve peak sales of $500 million.

In addition to Lumoxiti, two other novel drugs received approval in September - Teva's Ajovy and Verastem Oncology's Copiktra. Ajovy is for the preventive treatment of migraine in adults, and Copiktra is to treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma.

So far this year, 38 *novel drugs have been approved compared to 34 during the same period last year. A total of 46 novel drugs passed FDA muster last year. *Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

Now, let's take a look at the biotech stocks that await a ruling from the FDA in October 2018.