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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 1 | Issue 20
November 15, 2019

Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD

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Clinical Update

Breakthrough therapy for cystic fibrosis receives FDA approval

On Oct. 21, 2019, the U.S. Food and Drug Administration (FDA) approved Trikafta™ (elexacaftor/tezacaftor/ivacaftor) oral tablets as the first triple combination treatment for cystic fibrosis (CF) in patients twelve years of age and older with a specific genetic marker known as the F508del mutation. CF is a rare, life-threatening disease and is characterized by thick mucus buildup in the lungs, digestive tract, and other parts of the body, that results in severe respiratory and digestive complications, including infections. With the approval of Trikafta®, patient eligibility for therapy broadens from 50% of CF patients to approximately 90% of CF patients. Trikafta® received Breakthrough Therapy, Fast Track, Orphan Drug, and Priority Review designations and was approved approximately 4 months earlier than the FDA’s original goal review date.

Safety First

Mylan Pharmaceuticals issues voluntary recall on popular anti-anxiety medication

On Oct. 25, 2019, Mylan Pharmaceuticals announced a precautionary voluntary recall of one lot of alprazolam 0.5mg tablets due to the potential presence of a foreign substance. Alprazolam, also referred to by its trade name, Xanax®, is a medication used for the management of anxiety and panic disorders, along with their associated symptoms. Mylan has yet to release the identity of the foreign substance but has indicated that although the potential clinical impact is expected to be rare if foreign material is present, a small risk of infection should not be ruled out. Mylan has notified distributors and customers by letter and is coordinating the return of all affected products. To date, Mylan has not received any reports of adverse events related to the affected batch.

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From the Industry

Biogen reverses course and elects to file for FDA approval of experimental Alzheimer’s drug

On Oct. 22, 2019, Biogen announced it would be seeking FDA approval for aducanumab to treat individuals with mild cognitive impairment and early signs of Alzheimer’s disease. This announcement comes after previously announcing in March that it was halting two ongoing clinical trials. Alzheimer’s disease is a type of dementia that causes problems with memory, thinking and behavior. Biogen reversed their decision not to file for FDA approval after additional data analysis revealed a possible benefit in a specific subset of patients that received a higher dose of the medication. While the announcement brings hope for a new treatment option, some experts are cautious given the lack of published data and lack of benefit seen in previous trials. Biogen plans to present further detail on the new data analysis at a clinical meeting in December 2019.

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FDA Approvals

Recent FDA Approvals

New Dosage Approval: AmzeeqTM (minocycline)
Topical foam for the treatment of moderate to severe acne in patients 9 years of age and older [10/18/2019 – FOAMIX PHARMA INC]

Novel Drug Approval: TrikaftaTM (elexacaftor/tezacaftor/ivacaftor)
Oral tablet for the treatment of cystic fibrosis (CF) in patients twelve years of age and older who have at least one variation (F508del) in the CFTR gene [10/21/2019 – Breakthrough TherapyFast TrackOrphan DrugPriority Review – VERTEX PHARMS INC]

New Active Ingredient: VumerityTM (diroximel fumarate)
Oral capsule for the treatment of adult patients with relapsing forms of multiple sclerosis (MS) [10/29/2019 – ALKERMES]

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New Generics

New Generics Entering the Marketplace

*As of this issue, there were no new generics entering the marketplace. However, there are several projected launches we are monitoring, including:

OsmoPrep® (sodium phosphates)
Indication: Laxative
Dosage Form/Strength: Tablet
Projected Launch Date: November 2019

Endometrin® (progesterone)
Indication: Hormone
Dosage Form/Strength: Vaginal Insert
Projected Launch Date: November 2019

Afinitor® (Everolimus)
Indication: Immunosuppressant
Dosage Form/Strength: 2.5, 5 and 7.5mg tablets
Projected Launch Date: 4Q 2019