Late with the Weekly Roundup here due to some serious travel obligations which are still underway and afford me very little in the way of access to the Internet. Apologies. Had it been a low news-level week, I would have forgone the posting, but it was actually quite active – on Friday FDA issued a whopping 5 press releases in a single day.
And so here it is:
- FDA Approves First in Class Cholesterol Treatment – Twitter was aflutter on Friday with anticipation of the announcement by FDA that the agency was approving Praluent (alirocumab) – an injection approved for use in conjunction with diet and exercise as well as maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical athersclerotic cardiovascular disease. The treatment is a biologic – an antibody targeting a specific protein – PCSK9 and works by reducing the number of receptors on the liver that remove LDL cholesterol from the blood. A trial that will look at the impact on cardiovascular risk when combined with statin therapy is ongoing. The release from the sponsors – Sanofi and Regeneron – can be found here. Also earlier in the day came the news that the CHMP had made a favorable recommendation for approval.
- FDA Approves Odomzo for Most Common Skin Cancer – Another important approval came this week with the announcement that the agency was approving Odomzo (sonidegib) to treat patients with locally advanced basel cell carcinoma that has recurred in patients who have had surgery or radiation therapy and are not candidates for repeat treatment. Odomzo works by inhibiting a pathway that is active for basel cell tumors that may stop or discourage growth. According to the company release, Odomzo approval came from a pivotal Phase II trial.
- FDA Approves New Differentiating HIV Antibody Test – The agency announced approval this week of the first test that will allow for the differentiation of antibodies for HIV-1, HIV-2 and HIV-1 p24 antigen in human serum or plasma specimens. The assay may be used to screen organ donors but not for use in screening blood donors except in urgent situations.
- FDA to Hold REMS Public Meeting – FDA is announcing a public meeting entitled “REMS – Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access” to be held on October 5 at the FDA White Oak Campus.
That’s it for me this week folks. I hope you had a good weekend.