Drugs Approved by FDA Expected to Exceed 50 in 2018

More than half of 2018 is already over. FDA has approved the marketing of 30 drugs by August 11, 2018. And the big pharmaceutical enterprises have successively released their 2018 H1 financial reports. Here, I’d like to list the FDA’s review progress of noteworthy pharmaceutical products in the second half of 2018 mainly according to the disclosed data. Presumably, FDA is expected to approve 51 new drugs in 2018.

I. Drugs approved by FDA expected to reach 51 in 2018, and the world’s 6^th anti-PD-(L)1 antibody Cemiplimab to be marketed soon

More than half of 2018 is already over. FDA has approved the marketing of 30 drugs so far. Here, I’d like to list the review progress of noteworthy pharmaceutical products in the second half of 2018 according to the disclosed information of enterprises. Presumably, the total of drugs approved by FDA in 2018 will exceed that in 2017 to exceed 50, with the drug information as follows:

The following points are noteworthy:

1. Stannsoporfin is not expected to be approved

Mallinckrodt plc released the registration progress of this drug on May 3, 2018. FDA Advisory Committee voted against (21:3) the marketing application of the drug, thus, FDA is expected not to approve the marketing application thereof.

2. FDA is to approve the world’s 6^th anti-PD-(L)1 antibody Cemiplimab

There have been 5 anti-PD-(L)1 antibodies approved for marketing by FDA in the world, and globally, Junshi Biosciences’ Teruipuli mAb, Innovent Biologics’ sintilimab, Hengrui Medicine’s camrelizumab, and Sanofi’s Cemiplimab are all at the marketing approval stage. FDA is expected to approve Sanofi’s Cemiplimab on October 28, 2018, with the indication being metastatic/locally advanced cutaneous squamous cell carcinoma.

3. There will be the first ASO drug for familial hyperchylomicronemia syndrome

FDA Advisory Committee voted for (12:8) the marketing of the antisense oligonucleotide (ASO) WAYLIVRATM (volanesorsen) on May 10, 2018. The thrombocytopenia caused by volanesorsen is controversial, however, the drug effectiveness is apparent. The drug is generally considered to require REMS after marketing.

4. The other 2 CGRP monoclonal antibodies will be approved for marketing

The migraine drug Aimovig (erenumab) of Amgen/Novartis was approved for marketing as scheduled on May 17, 2018, which was ahead of Teve’s relevant drug to become the first-in-class CGRP monoclonal antibody drug approved, and is one of the high-profile drugs in 2018.

Besides erenumab, Teva’s Fremanezumab and Eli Lilly’s Galcanezumab will also be successively approved for marketing.

5. There will be another antiviral STR drug for HIV

Doravirine is a NNRTI drug, and the fixed-dose combination of DOR/3TC/TDF showed significant clinical benefits in DRIVE-FORWARD (NCT02275780) and DRIVE-AHEAD (NCT02403674) clinical studies.

Other high-profile drugs also include 2 tetracyclines, many kinase inhibitors, and the influenza drug baloxavir marboxil that has been approved for marketing in Japan.

Other drugs will not be further discussed here due to the length limitations.

Presumably, FDA is expected to approve 51 new drugs in 2018.

Read more: FDA’s Review Progress of Noteworthy Pharmaceutical Products in the Second Half of the Year

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