Top 5 drugs in the pipeline

While approval of several drugs have been delayed due to COVID-19, FDA has still cleared more than 30 new drugs this year — ahead of its average rate, a new OptumRx report says.

Here are the top 5 drugs in the pipeline for 2020 — either approved recently or expected to garner FDA clearance this year — according to OptumRx’s most recent Drug Pipeline Insight Report.

1. Valoctocogene roxaparvovec (Roctavian, BioMarin) to treat hemophilia A in adults. While an FDA decision on whether or not the approve the medication was expected by August 21, the agency requested additional data from BioMarin.

Related: Top 3 drugs to watch in second half of 2020​

“Existing treatments for this condition are extremely expensive, costing up to $500,000 per year. Valoctocogene roxaparvovec would offer a one-time gene therapy that could replace the need for these treatments in some patients,” OptumRx wrote.

The projected wholesale acquisition cost (WAC) for valoctocogene roxaparvovec is expected to be in the range of $2 million to $3 million per one-time dose.

2. Filgotinib (Jyseleca, Gilead Sciences) to treat moderate-to-severe rheumatoid arthritis (RA). The drug has yet to obtain FDA approval.

“Just one day prior the scheduled decision date, the FDA announced that it will require additional data from two ongoing safety studies of the drug. Relatedly, the FDA has expressed concerns regarding the overall benefit/risk profile of filgotinib at the 200 mg. dose used in trials,” OptumRx wrote. “Industry analysts speculate that if these concerns cannot be satisfied, the entire development program may be dropped by the manufacturer.”

3. Brexucabtagene autoleucel (Tecartus, Kite, a Gilead company) treats adult patients with relapsed or refractory mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin’s lymphoma (NHL). It was approved in late July.

Notably, Tecartus is a chimeric antigen receptor T-cell (CAR T) therapy, which leverages and strengthens the power of a patient’s immune system to attack cancer cells.

Related: FDA clears first cell-based gene therapy for lymphoma​

“Tecartus becomes the first CAR T-cell therapy for MCL, offering an additional treatment option for patients with relapsed or refractory MCL that only requires a one-time dose administered by IV infusion,” OptumRx wrote.

In trials with a median follow-up period of 12.3 months, 93% of patients responded to a single infusion of Tecartus, including 67% of patients who achieved a complete response.

4. Subcutaneous ofatumumab (Kesimpta, Novartis), approved in late August, treats relapsing forms of multiple sclerosis (MS). Ofatumumab is currently available in intravenous (IV) form as Arzerra, which is FDA approved for the treatment of chronic lymphocytic leukemia.

Kesimpta will be entering a crowded MS marketplace, competing not only with Aubagio, but also with other well established oral and injectable products with different mechanisms of action, OptumRx said.

“Analysts say that being self-administered by subcutaneous injection would give Kesimpta a key advantage,” OptumRx said.

5. Tafasitamab-cxix (Monjuvi, MorphoSys AG), approved in late July, is the first FDA-approved, second-line regimen for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Monjuvi is to be used in combination with lenalidomide (Revlimid). It will be competing with polatuzumab vedotin (Polivy), which was approved in June 2019 for a similar indication.

Read more: Top 3 drugs expected in first half 2020​