EMA’s human medicines committee (CHMP) recommended two medicines for approval at its February 2020 meeting.
The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
The generic medicine Tigecycline Accord (tigecycline) received a positive opinion for the treatment of complicated skin and soft tissue (i.e. tissues just below the skin) infections and complicated intra-abdominal infections.
The Committee recommended extensions of indication for Alunbrig, Ofev and Otezla.
The CHMP also recommended the addition of a new pharmaceutical form for Entyvio: a 108 mg solution for injection to be given subcutaneously.
The CHMP adopted a negative opinion for an extension of indication for Emgality (galcanezumab) to add prevention of attacks in adults who suffer from episodic cluster headache.
For more information on this negative opinion, see the question-and-answer document in the grid below.
The CHMP started a review of medicines for which studies have been conducted by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. This follows a good clinical practice (GCP) inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the EU.
The Committee also started a review of the cancer medicine Yondelis (trabectedin), used to treat ovarian cancer and soft-tissue sarcoma (a type of cancer that develops from the soft, supporting tissues of the body). The review started after a clinical study (OVC-3006) investigating the use of Yondelis in patients with ovarian cancer was stopped ahead of time, because an interim analysis of the results showed that, overall, patients treated with Yondelis plus pegylated liposomal doxorubicin (PLD, another cancer medicine) did not live longer than patients given PLD alone.
For more information, see the start-of-referral documents in the grid below.
The application to extend the use of Axumin (fluciclovine (18F)) in the diagnosis and continuing assessment of glioma (a type of brain tumour) was withdrawn.
The application for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in the treatment of metastatic non-small cell lung cancer that has not been treated previously was also withdrawn.
Question-and-answer documents on these withdrawals are available in the grid below.
The agenda of the February meeting is published on EMA's website. Minutes of the January 2020 CHMP meeting will be published in the coming weeks.
Key figures from the February 2020 CHMP meeting are represented in the graphic below.
| Name of medicine | Fetcroja |
| International non-proprietary name (INN) | cefiderocol |
| Marketing-authorisation applicant | Shionogi B.V. |
| Therapeutic indication | Treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options |
| More information | Fetcroja: Pending EC decision |
| Name of medicine | Tigecycline Accord |
| INN | tigecycline |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of complicated skin and soft tissue infections and complicated intra-abdominal infections |
| More information | Tigecycline Accord: Pending EC decision |
| Name of medicine | Alunbrig |
| INN | brigatinib |
| Marketing-authorisation holder | Takeda Pharma A/S |
| More information | Alunbrig: Pending EC decision |
| Name of medicine | Ofev |
| INN | nintedanib |
| Marketing-authorisation holder | Boehringer Ingelheim International GmbH |
| More information | Ofev: Pending EC decision |
| Name of medicine | Otezla |
| INN | apremilast |
| Marketing-authorisation holder | Amgen Europe B.V. |
| More information | Otezla: Pending EC decision |
| Name of medicine | Emgality |
| INN | galcanezumab |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information | Emgality: Pending EC decision |
| Name of medicine | Entyvio |
| INN | vedolizumab |
| Marketing-authorisation holder | Takeda Pharma A/S |
| More information | Entyvio: Pending EC decision |
| Name of medicine | Panexcell Clinical Laboratories Priv. Ltd |
| More information | Panexcell: Article-31 referral |
| Name of medicine | Yondelis |
| INN | trabectedin |
| More information | Yondelis: Article-20 procedure |
| Name of medicine | Axumin |
| INN | fluciclovine (18F) |
| Marketing-authorisation holder | Blue Earth Diagnostics Ireland Ltd |
| More information | Axumin: Withdrawn application |
| Name of medicine | Opdivo / Yervoy |
| INN | nivolumab / ipilimumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information |