Six medicines recommended for approval, including one orphan
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting.
The CHMP recommended granting a conditional marketing authorisation for Rubraca (rucaparib), for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicine during its development.
Juluca (dolutegravir / rilpivirine) received a positive opinion for the treatment of human immunodeficiency virus (HIV) infection.
Two biosimilar medicines were recommended for approval by the Committee: Kanjinti (trastuzumab) for the treatment of breast and gastric cancer; and Zessly (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Two generic medicines received a positive opinion from the CHMP: Pemetrexed Krka (pemetrexed), for the treatment of malignant pleural mesothelioma and non-small cell lung cancer; and Prasugrel Mylan (prasugrel), for the prevention of atherothrombotic events.
Negative opinions on two new medicines
The CHMP adopted a negative opinion for Dexxience (betrixaban). Dexxience was expected to be used for the prevention of venous thromboembolism.
The Committee also adopted a negative opinion for Eladynos (abaloparatide). Eladynos was intended to be used to treat osteoporosis.
Negative recommendation on new medicine following re-examination
The CHMP confirmed its previous recommendation to refuse the granting of a marketing authorisation for Aplidin (plitidepsin). Aplidin was expected to be used to treat adults with multiple myeloma. This followed a request from the applicant for the re-examination of the Committee’s negative opinion for the medicine adopted at the December 2017 meeting.
Start of re-examination of recommendation on new medicine
The applicant for Nerlynx (neratinib) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the February 2018 meeting. The CHMP will now re-examine the opinion and issue a final recommendation.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indications for Cabometyx, Ivemend and Repatha.
Start of re-examination of recommendation on extension of therapeutic indication
The applicant for Sutent (sunitinib) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the February 2018 meeting. The CHMPwill now re-examine the opinion and issue a final recommendation.
Start of referral: omega-3 fatty acid medicines
The CHMP started a review of the use of omega-3 fatty acid medicines in patients who have had a heart attack, following research showing that these oral products may not prevent recurrence of heart disease or stroke.
Outcome of review on retinoid medicines
The CHMP concluded its review of retinoid medicines, and confirmed that retinoids can harm the unborn child and must not be used during pregnancy. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids.
Withdrawal of application
An application to extend the indication of Aranesp (darbepoetin alfa) to treat anaemia in patients with myelodysplastic syndromes has been withdrawn. A question-and-answer document on this withdrawal is available.