Dive Brief:
- The most recent meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use saw six recommendations for approval, including two biosimilars: Amgen Inc. and Allergan plc's Herceptin (trastuzumab) biosimilar Kanjinti for the treatment of breast and gastric cancer; and Novartis AG's Remicade (infliximab) copycat Zessly for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
- The panel issued three negative opinions, including a second no recommendation following re-examination of Spanish company PharmaMar S.A.'s Aplidin multiple myeloma. The initial negative opinion was in December 2017.
- For 2018 thus far, the CHMP has issued 18 positive and 4 negative opinions on new medicines, and 12 positive opinions on extensions of therapeutic indications.
Dive Insight:
Friday's recommendation for approval of ViiV Healthcare's Juluca, a combination of its Tivicay (dolutegravir) and Johnson & Johnson's Edurant (rilpivirine) brings a once-daily, single tablet maintenance therapy for HIV/AIDS nearer to the market in Europe.
Juluca, which will cut the number of antiretrovirals that patients have to take, was approved as the first two-drug regimen for maintenance treatment in the U.S. in November 2017.
"[This recommendation] takes us a step closer to… the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed; Juluca is expected to be the smallest single-pill regimen in the market," said Deborah Waterhouse, CEO of ViiV, a joint venture between GlaxoSmithKline plc and Pfizer Inc., in a statement.
The responses weren't all positive, with negative opinions for Portola Pharmaceuticals, Inc.'s Dexxience (betrixaban) and Radius Health Inc.'s Eladynos (abaloparatide), both already approved in the U.S.
Portola's oral, once-daily Factor Xa inhibitor had setbacks en route to the U.S., where it is available as Bevyxxa for prophylaxis for patients hospitalized with an acute medical illness and at high risk of venous thromboembolism. The drug did not meet its primary endpoint of reduction in the number of thrombotic events in the Phase 3 APEX trial.
According to the CHMP, the study presented in the European application "did not satisfactorily show that Dexxience’s benefits outweighed its risk when used for preventing blood clots in patients admitted to hospital for recent medical illness." This included the observation that patients treated with Dexxience had more episodes of bleeding than those treated with the comparator, enoxaparin. The CHMP also did not consider the results of the study reliable because some results of tests for blood clots were not available.
Perhaps the toughest blow, though, was the negative recommendation following re-examination of PharmaMar S.A.'s Aplidin (plitidepsin). This drug, derived from a sea squirt and partnered with Chugai, was submitted for use in adults with multiple myeloma.
In its initial review, the CHMP raised concerns that the main study showed "only a modest increase of around one month in the time patients given Aplidin lived without their disease getting worse, compared with those treated with dexamethasone alone." It also noted insufficient demonstration of improvement in overall survival and increased severity of side effects. Unfortunately for PharmaMar, reexamination did not change the committee's opinion. It's not yet clear what PharmaMar's next step for Aplidin will be.
The EMA nearly always takes the advice of the CHMP, though the recommendations are advisory.