MP-2026-NPH-G · Nephrada · Nephrology / IgA nephropathy
PRD planning workflow. The current state is highlighted.
Build disease-state awareness of proteinuria as a surrogate endpoint and establish nephrologist familiarity with APRIL inhibition ahead of anticipated FDA accelerated approval in Q1 2027.
Long-term eGFR slope data
Head-to-head versus budesonide formulations
No project yet
Pediatric data
No project yet
SO-NPH-01
Accelerated approval will be based on proteinuria; clinicians need confidence in the endpoint.
Linked initiatives (1)
SO-NPH-02
Payers have signalled that proteinuria alone will not support reimbursement.
Linked initiatives (1)
SO-NPH-03
Insights indicate fatigue and treatment burden are under-measured.
Linked initiatives (1)
Planned versus delivered, and activity versus outcome for this product.
Initiatives completed
0 / 3
1 at risk or blocked
Milestones
3 / 7 done
2 on time · 1 late · 1 overdue · 3 upcoming
Budget consumed
57%
$2.4M of $4.2M · initiatives $290k of $2.5M
Activity → outcome
48 → 17 → 3
Engagements → insights → actions for this product
Activity counts (engagements) are not outcomes. Insights and actions are shown alongside so that activity is read against what it produced. Budget figures for the plan come from Finance; initiative spend is entered by initiative owners.
Newest first. Each version records who changed the plan and what changed.
22 Jan 2026 · v2
Approved; added patient-advocacy objective.
By Dr. Helen Okafor · current version
18 Nov 2025 · v1
Initial pre-launch plan.
By Dr. Marcus Lindqvist
| Dependency | Dependent | Depends on | Type | Due | Status | Impact if delayed |
|---|---|---|---|---|---|---|
| DEP-0003 | GLOMERULAR-REG registry | FY2027 budget confirmation (Finance) (External) | Cross-functional | 15 Oct 2026 | Blocked | No eGFR data for HTA; access risk in GB/DE |
| Initiative | Type | Objective | Owner | Priority | Status | Progress | End |
|---|---|---|---|---|---|---|---|
| Proteinuria surrogate-endpoint education series | Medical education program | SO-NPH-01 | ABDr. Anna Becker | High | In progress | 62% | 15 Dec 2026 |
| IgAN eGFR-slope registry (GLOMERULAR-REG) | RWE project | SO-NPH-02 | NPDr. Nikolai Petrov | Critical | Blocked | 18% | 31 Dec 2028 |
| IgAN patient-advocacy advisory board | Advisory board | SO-NPH-03 | SLDr. Sophie Laurent | Medium | In progress | 50% | 30 Nov 2026 |
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