FDA Kicks Drug Approvals into Overdrive
The FDA granted approval to numerous specialty drugs last week.
The FDA hit back at criticism regarding a slow drug approval process last week, giving the greenlight to 7 new drugs between November 13, 2017, and November 16, 2017.
The FDA granted approval to a significant number of specialty drugs and brought to market the first smart pill, which may be able to track medication adherence for patients with schizophrenia.
Here’s a recap of the approvals on Specialty Pharmacy Times:
1. Dasatinib Approved to Treat Chronic Myeloid Leukemia in Pediatric Patients
Nearly all patients treated with dasatinib (Sprycel) achieved a complete cyotgenic response. Read more.
2. FDA Approves 'Smart' Pill That Tracks Adherence
Aripiprazole tablets with sensor (Abilify MyCite) transmits information to an app when ingested. Read more.
3. Orphan Drug Gets FDA Nod for Genetic Enzyme Disease
Vestronidase alfa-vjbk (Mepsevii) approved to treat mucopolysaccharidosis. Read more.
4. Biologic Drug Receives Approval for Eosinophilic Asthma
Benralizumab (Fasenra) demonstrates the ability to significantly deplete eosinophils and could reduce the need for oral steroid use. Read more.
5. FDA Expands Indication for Fulvestrant Combination to HR+/HER2- Breast Cancer
Fulvestrant (Faslodex) plus abemaciclib may improve progression-free survival among patients with advanced or metastatic breast cancer. Read more.
6. FDA Approves Prophylactic Hemophilia Drug to Prevent Bleeding
Emicizumab-kxwh (Hemlibra) demonstrated the ability to reduce bleeding events that require treatment in patients with hemophilia A. Read more.
7. Adjuvant Renal Cell Carcinoma Drug Receives FDA Greenlight
Sunitinib malate (Sutent) may improve disease-free survival among patients with renal cell carcinoma. Read more.