- Drug Coverage
- Hypertrophic Cardiomyopathy (HCM)
- Vaccines: 2023 Year in Review
- Eyecare
- Urothelial Carcinoma
- Women's Health
- Hemophilia
- Heart Failure
- Vaccines
- Neonatal Care
- NSCLC
- Type II Inflammation
- Substance Use Disorder
- Gene Therapy
- Lung Cancer
- Spinal Muscular Atrophy
- HIV
- Post-Acute Care
- Liver Disease
- Pulmonary Arterial Hypertension
- Safety & Recalls
- Biologics
- Asthma
- Atrial Fibrillation
- Type I Diabetes
- RSV
- COVID-19
- Cardiovascular Diseases
- Breast Cancer
- Prescription Digital Therapeutics
- Reproductive Health
- The Improving Patient Access Podcast
- Blood Cancer
- Ulcerative Colitis
- Respiratory Conditions
- Multiple Sclerosis
- Digital Health
- Population Health
- Sleep Disorders
- Biosimilars
- Plaque Psoriasis
- Leukemia and Lymphoma
- Oncology
- Pediatrics
- Urology
- Obstetrics-Gynecology & Women's Health
- Opioids
- Solid Tumors
- Autoimmune Diseases
- Dermatology
- Diabetes
- Mental Health
Development of rimonabant and CP-945,598 for obesity is discontinued
One month after Merck announced that the company was discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity, Sanofi-Aventis and Pfizer announced that they were also halting the development of their investigational CB-1 receptor antagonists (rimonabant and CP-945,598, respectively).
One month after Merck announced that the company was discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity, Sanofi-Aventis and Pfizer announced that they were also halting the development of their investigational CB-1 receptor antagonists (rimonabant and CP-945,598, respectively).
Sanofi-Aventis’ decision to stop the development of rimonabant came just weeks after the European Medicines Agency (EMEA) recommended that the European marketing authorization of rimonabant (European brand name Acomplia) be suspended because of an increased risk of psychiatric adverse events. After reviewing the available data, including postmarketing information, members of the EMEA’s Committee for Medicinal Products for Human Use (CHMP) stated that the risk of psychiatric disorders is approximately doubled in patients taking rimonabant versus those taking placebo.
Rimonabant is not approved by FDA. In June 2007, Sanofi-Aventis withdrew the rimonabant NDA from FDA consideration after FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended against approval of the drug.
Pfizer stated that its decision to discontinue development of CP-945,598 is based not on safety concerns but on “changing regulatory perspectives” on this class of drugs.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More
