Multinational pharmaceutical giants are getting ready to release new drugs this year in the local market amid intensifying competition to make the drugs safer and more effective.
Sanofi, which introduced Cerdelga (ingredient: eliglustat) for adults with type-1 Gaucher disease with the improved convenience of medication (once or twice a day) in January, is preparing to release several other treatments this year.
The company plans to release anti-diabetic drug Soliqua (insulin glargine), hyperlipidemia treatment Praluent (alirocumab), and atopic dermatitis therapy Dupilumab this year.
Soliqua is the first fixed ratio co-formulation (FRC) in Korea that combines insulin glargine and lixisenatide in a fixed ratio. It is a pen-type injection to treat diabetes.
Soliqua’s ingredients show better blood glucose control through complementary mechanisms than individual treatments.
The drug is used for patients with type-2 diabetes who have difficulty controlling blood sugar with conventional metformin and other hypoglycemic agents or basal insulin therapy.
Praluent, a hyperlipidemia treatment, received the first local approval in January 2017. As a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, the drug lowers LDL-C (low-density lipoprotein-cholesterol) in the blood by blocking the activity of PCSK9, which degrades the LDL receptor and increase the number of LDL receptors on the surface of hepatocytes.
Praluent is used for patients who cannot fully control LDL-C despite standard therapy. Target patients include high-risk cardiovascular groups such as acute coronary syndrome patients and those with familial hypercholesterolemia and Statin intolerance. It can be injected under the skin every two weeks.
Praluent reduced LDL-C of patients by 62 percent when administered together with Statin to patients whose LDL-C control was not adequately regulated with maximum tolerated dose (MTD) of Statin. About 79 percent of the patients reached the therapeutic goal (LDL-C<70mg/dL). The drug’s long-term (78 weeks) use was also efficient.
Praluent will be out in the market in two dosing types – 75 mg and 150 mg – to allow physicians to adjust and prescribe doses for different target patients.
Sanofi also plans to launch Dupilumab in the local market in the first half of the year. The drug was designated as a “breakthrough therapy” in the U.S. in 2014.
The FDA-designated breakthrough drugs can cure a disease or dramatically change the course of a disease in clinical stages.
The FDA approved Dupilumab in March 2017 after including its biologics license application (BLA) in the list of quick reviews.
In the local market, Dupilumab will be prescribed for adults with acute atopic dermatitis.
After releasing soft tissue sarcoma treatment Lartruvo (olaratumab), Lilly Korea will launch Olumiant (baricitinib), an oral medication for rheumatoid arthritis, and psoriasis treatment Talz (ixekizumab), this year.
Lartruvo came out on the market early this month. Olumiant and Talz received sales approval in December from the Ministry of Food and Drug Safety.
Lartruvo prolonged the overall survival by one year, compared with the existing standard therapy, in clinical trials.
Olumiant also proved better efficacy than the existing treatment Humira (adalimumab), signaling a tougher competition in the rheumatoid arthritis market.
Olumiant showed a statistically meaningful clinical improvement, compared to conventional drugs Humira and methotrexate (MTX), in four clinical trials involving more than 3,000 patients, including 500 Asians.
Olumiant targets adult patients with moderate to severely active rheumatoid arthritis who do not adequately respond to or tolerate one or more anti-rheumatic agents.
Talz, which beat TNF(tumor necrosis factor)-α inhibitor Enbrel (etanercept) and interleukin 12/23 inhibitor Stelara (ustekinumab) in clinical trials, is a promising item for Lilly Korea to threaten the market dominance.
In clinical trials that directly compared with Enbrel and Stelara, Talz overwhelmingly outpaced the other two in the number of patients that reached 90 in psoriasis area and severity index (PASI).
PASI is a tool to assess the severity of psoriasis, based on the extent of erythema, scar thickness and lesions in the psoriatic region. PASI 90 means 90 percent or more reduction in their PASO score, which is a recovery to the almost clean skin.
Lilly Korea said Talz elevated the standard treatment criteria, currently at PASI 75, to the next level.
AstraZeneca is seeking approval for Imfinzi (durvalumab), an anti-PD-L1 (programmed death-ligand 1) immunotherapy.
The drug targets non-small cell lung cancer. The phase-3 clinical trials (PACIFIC)’ interim results showed that Imfinzi-administered patients had 16.8 months of none-progression survival period, 11 months more than the 5.6 months of the placebo-administered group.
AstraZeneca Korea is continuing research to discover more anti-cancer drugs.
In November last year, the FDA received the application for approval to expand the indications of Imfinzi for the treatment of non-operative non-small cell lung cancer patients with no progress of the disease after chemotherapy. Then, the FDA put Imfinzi on the fast-track review list.
Korea Otsuka Pharmaceuticals’ Iclusig, a tyrosine kinase inhibitor (TKI), will be another new leukemia treatment, as the Health Insurance Review & Assessment Service’s drug reimbursement and evaluation committee recognized the drug as eligible for insurance benefits late last year.
According to the company, Iclusig is the only drug that proved useful on T315I-positive patients.
Iclusig’s study showed clinical improvements in patients with T315I-positive CML (acute-phase chronic myelogenous leukemia) patients and Ph+ALL (Philadelphia chromosome-positive acute lymphocytic leukemia) patients.
The strength of Iclusig is that patients can take the medication once a day, regardless of meals. Iclusig aims CML or Ph+ALL adult patients, including T315I-positive, who are not treatable with other TKIs.
Bayer Korea’s contraceptive device Kyleena, classified as a hormone-based drug, is also ready to arrive in Korea next month.
Inserted inside the uterus, Kyleena provides five years of contraception. It is a follow-up device to Mirena.
Even though the duration of contraception is the same, Kyleena’s T-body is smaller, making it more convenient to insert the device. The new device will have fewer side effects because it comes in the minimal dose of 19.5 mg, compared with Mirena’s 52 mg, Bayer Korea said.
Kyleena has a silver ring for ultrasound observation. The company said its contraceptive effect was 99 percent.