The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency." In addition, the CHMP offered support for eight medicines from companies including Bristol Myers Squibb Co., Pfizer Inc., Novartis AG and Sanofi SA, among the latest to gain the support of the body, which issued positive opinions on marketing authorization applications for each at its April meeting.
The rolling remdesivir review will allow the CHMP to appoint rapporteurs to lead an evaluation of the drug at the same time as ongoing development and to review data as they become available, it said, rather than requiring all data supporting an MAA to be submitted at the evaluation's start. However, the move "does not imply that its benefits outweigh its risks," the CHMP said, putting it on more cautious footing than the U.S. FDA, which on Friday said that "the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug's use."
Gilead shares (NASDAQ:GILD) fell 4.8% to close at $79.95 on Friday.
Several rolling review cycles can be carried out as data continue to emerge, the EMA said, with each cycle lasting around two weeks depending on the amount of data to be assessed. The CHMP's decision to start the review was based on preliminary results of the U.S.-based National Institute for Allergy and Infectious Diseases Adaptive COVID-19 Treatment Trial, "which suggest a beneficial effect of remdesivir in the treatment of hospitalized patients with mild to moderate or severe COVID-19," though "it is too early to draw any conclusions regarding the benefit-risk balance of the medicine," the regulator said.
To get a broader picture of the medicine's potential, the CHMP will also take into consideration additional investigations of remdesivir, including results of a China-based trial recently published online by The Lancet that yielded "inconclusive findings on the primary outcome of time to clinical improvement," according to University of Edinburgh professor John Norrie, who wrote a commentary accompanying an article.
As in the U.S., remdesivir is not yet approved for marketing, though it is also available to European patients through approved avenues such as clinical trials and compassionate use programs.
Support for new anemia, AML and asthma drugs
In addition to highlighting its work on remdesivir, the CHMP unveiled its support of potential EU approval for two orphan drugs, Reblozyl (luspatercept) in certain adults with transfusion-dependent anemia and Daurismo (glasdegib) for the treatment of acute myeloid leukemia. They also include support for Novartis' Enerzair Breezhaler, the first once-daily triple-combination therapy for adults with asthma not adequately controlled by a long‑acting beta2‑agonist and a high-dose inhaled corticosteroid combination.
In addition, the committee recommended extended indications for some approved drugs and a significant new route of administration for another, the Janssen multiple myeloma medicine Darzalex (daratumumab). The latter could vastly improve the convenience of Darzalex delivery with a minutes-long subcutaneous administration instead of an hours-long I.V. delivery. Janssen Biotech Inc. and the medicine’s originator, Genmab A/S, reported FDA approval for the change in the U.S. on Friday, a product the incorporation of technology from Halozyme Therapeutics Inc.
Other medicines poised to gain expanded labels in the EU market included Braftovi (encorafenib), Cablivi (caplacizumab), Carmustine Obvius (carmustine), Ecalta (anidulafungin), Harvoni (ledipasvir / sofosbuvir), Kalydeco (ivacaftor), Sovaldi (sofosbuvir), Taltz (ixekizumab) and Ultomiris (ravulizumab).
Reblozyl, developed by Acceleron Pharma Inc. and BMS-owned Celgene Corp., became the first and only FDA-approved erythroid maturation agent in November 2019. If approved by the EMA, Reblozyl would secure a similar distinction in that market, where it's intended for the treatment of adults with transfusion-dependent anemia associated with myelodysplastic syndromes (MDS) or beta-thalassemia. The benefits of Reblozyl are its ability to reduce the number of transfusions in patients with MDS or beta-thalassemia, the CHMP said.
Citing the benefits provided by Enerzair Breezhaler in its ability to improve lung function as measured by FEV1 and to reduce exacerbations of asthma, the CHMP also adopted a positive opinion for it, along with an optional electronic sensor that can be co-packed with the product. The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient, sending data to an smartphone app or other suitable device, the committee said. The CHMP also adopted a positive opinion for Zimbus Breezhaler, which it said is a duplicate of the product.
The CHMP offered additional positive opinions for Sanofi's biosimilar insulin aspart for diabetes mellitus; a hybrid version of the metastatic prostate cancer cabazitaxel and generic fingolimod, both from Accord Healthcare S.L.U.
Alongside the positive opinions, the CHMP recommended the suspension of all ranitidine medicines in the EU due to the presence of low levels of N-nitrosodimethylamine, and the EMA completed its review of Picato (ingenol mebutate, LEO Pharma A/S), a gel for treating actinic keratosis. It concluded that the medicine may increase the risk of skin cancer and that its risks outweigh its benefits.